Aventis Pasteur Bayer BioPort Cargill Turkey Products Chiron Behring Coca-Cola ConAgra Foods Frito-Lay Glaxo Wellcome Jade Pharmacy Kellogg Lederle Laboratories North American Vaccine Novartis Consumer Health Procter & Gamble Roche SmithKline Beecham Unilever Wegmans Food Markets Wilson Foods Company ActHIB Certiva Coca-Cola Classic Contac Dexatrim  Diet Coke Dr. Pepper Eskornade Fruitopia Strawberry  Passion Fresca Soda Pop  Havrix Infanrix IPOL Lay's Classic Potato Chips  Lotronex Minute Maid Nestea Iced Tea OmniHIB PNU-IMUNE23 Powerade StarLink  Trasylol Triaminic alosetron aspartam bromiany Cry9C protein drożdże Escherichia coli O157H7 FD&C Yellow No. 5. fenylpropanolamina  fragmenty uszczelki guarana extract kawałki szkła  kwas arystolochowy Listeria monocytogenes pleśnie transgeniczna kukurydza  ukryta laktoza ukryta pszenica ukryte migdały ukryte orzechy ziemne ukryte składniki mleczne ukryty acesulfam K ukryty cukier ukryty sód ukryty sztuczny barwnik żywność funkcjonalna

Część
II
Firmy
(kolejność alfabetyczna)
Markowe produkty
(kolejność alfabetyczna)
Zagrożenia zdrowia
(kolejność alfabetyczna)
Aventis Pasteur
Bayer
BioPort
Cargill Turkey Products
Chiron Behring
Coca-Cola
ConAgra Foods
Frito-Lay
Glaxo Wellcome
Jade Pharmacy
Kellogg
Lederle Laboratories
North American Vaccine
Novartis Consumer Health
Procter & Gamble
Roche
SmithKline Beecham
Unilever
Wegmans Food Markets
Wilson Foods Company
ActHIB
Certiva
Coca-Cola Classic
Contac
Dexatrim 
Diet Coke
Dr. Pepper
Eskornade
Fruitopia Strawberry Passion
Fresca Soda Pop
 Havrix
Infanrix
IPOL
Lay's Classic Potato Chips
Lotronex
Minute Maid
Nestea Iced Tea
OmniHIB
PNU-IMUNE23
Powerade
StarLink 
Trasylol
Triaminic
alosetron
aspartam
bromiany
Cry9C protein 
drożdże
Escherichia coli O157H7
FD&C Yellow No. 5.
fenylpropanolamina 
fragmenty uszczelki
guarana extract
kawałki szkła 
kwas arystolochowy
Listeria monocytogenes
pleśnie
transgeniczna kukurydza 
zatajona farba
zatajona laktoza
zatajona pszenica
zatajone migdały
zatajone orzechy ziemne
zatajone składniki mleczne
zatajony acesulfam K
zatajonycukier
zatajony sód
żywność "funkcjonalna"

 
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Farba i odpady w przyprawie sprzedawanej pod marką Degusta

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2. grudnia, 2000r. "GAZETA WYBORCZA"
 Farba, marchewka, sól, odpady
Fałszywa Degusta

W podrzeszowskiej Lubenii policjanci nakryli nielegalną wytwórnię przyprawy Degusta. Przepis był prosty: wysuszona marchewka, natka pietruszki, bliżej nieokreślone odpady, sól, cukier i... sproszkowana farba. W ręce policji wpadła linia technologiczna i 14 ton gotowej przyprawy. Wystarczyłoby to do wyprodukowania 70 tys. torebek. W magazynie było 50 bel opakowań na kolejne 300 tysięcy torebek oraz ponad dziewięćdziesiąt worków soli kuchennej, susz z marchwi i pietruszki oraz cukier.

Do ujawnienia sprawy przyczynili się detektywi słynnego Krzysztofa Rutkowskiego. "Gazeta" dowiedziała się nieoficjalnie, że firmę Rutkowskiego zatrudnił producent Degusty - firma Vitpol, która trzy tygodnie temu poprosiła o wyśledzenie, kto produkuje fałszywą przyprawę.

Do Vitpolu informacje o tym, że podróbka pojawiła się na rynku, dotarły ponad miesiąc temu. Nielegalny produkt był w sklepach centralnej Polski, m. in. w Mazowieckiem i Świętokrzyskiem.

Małgorzata Bujara, Rzeszów


Transgeniczna kukurydza w produktach kilku firm

(WPŁYW ŻYWNOŚCI TRANSGENICZNEJ
NA ŚRODOWISKO I ZDROWIE CZŁOWIEKA)

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December 5, 2000
3 Additional Bulk Products Associated with Starlink Recall

Washington, DC (SafetyAlerts) - The Food and Drug Administration (FDA) announced today three additional recalls associated with Starlink corn product recall.

These products were manufactured using an ingredient which appeared to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption.

This is the first public notice of these Class II recalls issued by FDA.   The product recalls announced today are:

PRODUCT
Lauhoff CCF100 Tiny Flakes packaged in 50-pound bags, used in the brewing industry.

Recall #F-072-1.

CODE
Lot J30K00CJM

MANUFACTURER
Bunge Lauhoff Grain Company, Crete, Nebraska.

RECALLED BY
Bunge Lauhoff Grain Company, St. Louis, Missouri, by telephone and fax on November 22, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Pennsylvania and Wisconsin.

QUANTITY
643.5 cwt (hundred weight).

PRODUCT
Yellow Corn Flour:
MASECA FLOUR:
50 # & Tote Bag Regular #0 Yellow Sam
50 # & Tote Bag Regular #0 Yellow
50 # Regular #1 Yellow
50 # Premium #0 Yellow With CMC
50 # Premium #8 Yellow
50 # Taco Shell #1 Yellow
50 # Chip Delight #4 Yellow
50 # & Tote Bag Chip Delight #6 Yellow
50 # & Tote Bag Taco Shell #6 Yellow
50 # Taco Shell #6 Yellow With Vit.
50 # Tortilla Thin #1 Yellow
50 # Premium #3 Yellow
MASA MIXTA
50 # Tortilla #1 Yellow
50 # Tortilla #2 Yellow
50 # Tortilla #3 Yellow
50 # Tortilla #3 (3YS) Yellow
50 # & Tote Bag Tortilla Chip #1 Yellow
50 # Tortilla Chip #55 Yellow
50 # & Tote Bag Corn Chip #4 Yellow
50 # Corn Chip #8 Yellow
50 # Taco #1 Yellow
50 # Taquito #2 Yellow
50 # & Tote Bag Taco #6 Yellow
50 # & Tote Bag Tortilla Chip #9 Yellow Especial
50 # & Tote Bag Tortilla Chip #11 Yellow Especial
50 # Taquito #50/50 Yellow.

Recall #F-073-1.

CODE
All yellow corn flour manufactured since 1/1/00.

MANUFACTURER
Azteca Milling, Irving, Texas.

RECALLED BY
Manufacturer, by press release on October 13, 2000, and by letter dated November 3, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Undetermined.

PRODUCT
Bulk dry soup mixes packaged in plastic bags in cardboard shipping cartons: a) Creamy Chicken Noodle Soup item 741480 - 26 lb. bulk box; b) Corn Chowder Soup item 741520 - 19 lb. bulk box item 171520 - 5 lb. bulk box.

Recall #F-070/071-1.

CODE
Item number 741480, 26 pounds, lot number 10/9/00
Item number 741520, 19 pounds, lot number 10/5/00
Item number 171520, 5 pounds, lot number 10/9/00.

MANUFACTURER
John B. Sanfilippo & Son, Inc., Elk Grove Village, Illinois.

RECALLED BY
Manufacturer, by telephone on October 18, 2000, followed by letter on October 19, 2000. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION
Pennsylvania, Ohio, Kansas, Iowa.

QUANTITY
883 pounds were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
 


Potencjalnie śmiercionośna Escherichia coli 0157H7 
w mielonym mięsie wołowym

(Bakterie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)

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December 5, 2000
Over 1 Million Pounds of Ground Beef Recalled in 21 States

Green Bay, WI (SafetyAlerts) - Green Bay Dressed Beef Inc., also doing business as American Foods Group, is voluntarily recalling approximately 1.1 million pounds of ground beef that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

E. coli 0157:H7 is a potentially deadly bacteria that can cause bloody diarrhea and dehydration. The very young, the elderly, and persons with compromised immune systems are the most succeptible to foodborne illness.

Retail packages identifiable to consumers includes:

     
  • "B Bar Brand 100% Pure Ground Beef" in frozen 3 pound tubes with a sell by date of Nov/02/01, bearing the establishment number Est. 410.  This product was distributed to Indiana, Iowa, Ohio and Wisconsin.
  • "Kroger Ground Beef 75/25", "Kroger Ground Round 85/15" and Kroger Ground Beef Sirloin 90/10" in 1.5 pound packages with a production code of 0308, bearing the establishment number Est. 18076.  This product was distributed to Memphis, Tennessee.
  • "Kroger Ground Beef", "Kroger Ground Chuck", Kroger Ground Round" and "Kroger Ground Sirloin" in 1, 3 and 5 pound tubes with a sell by date of Nov/20/00, bearing the establishment number Est. 410.   This product was distributed to Georgia, Indiana, Kentucky, Michigan, Ohio, Tennessee and Virginia.
In a statement released by Kroger, the company stated that they are cooperating with the American Foods Group recall.

Kroger is asking consumers to check their freezers for any ground beef dated from November 4 through November 22 that was purchased from Kroger, King Soopers, City Market or Hilander stores in the following states: Ohio, West Virginia, Kentucky, Indiana, Illinois, Missouri, Michigan, Tennessee, Arkansas, Mississippi, Colorado and Wyoming. Consumers should return this ground beef to the store for a full refund or replacement.

Kroger is also asking customers to check their freezers for Kroger-brand ground beef purchased in one-, three- or five-pound tubes dated November 19 or November 20 from Kroger stores in the following states: Georgia, South Carolina, Alabama, Tennessee, Kentucky, Virginia, West Virginia and North Carolina. This ground beef should also be returned to the store for a full refund or replacement.

Additional ground beef products for further processing, produced on Nov. 2 and 3, are also being recalled.  According to a press release issued by American Foods Group, the following products are also included:

     
  • 2,900 pounds of the product recalled was produced in 5 pound tubes bearing the brand name Sysco Supreme Angus and carries the identification of USDA Establishment No. 410, distributed by Sysco Corp. The production date of these tubes is 11/02/00 and was shipped to the following states: Michigan, Florida.
  • 38,623 pounds of product recalled was produced in 10 pound tubes with the box bearing the brand name Sysco Classic and identification of USDA Establishment No.410, distributed by Sysco Corp. The production date of these tubes is 11/02/00 and was shipped to the following states: Florida, Michigan, North Carolina, Texas.
"Because of the potential hazard of foodborne illness from consumption of meat products contaminated with pathogens such as the E. coli 0157:117 bacteria, I urge consumers who have purchased the suspect product not to eat it and return it to the place of purchase,"said Thomas J. Billy, FSIS administrator. "USDA is informing the public so consumers who may have purchased and stored the product in their refrigerators or freezers can know to check."

Consumers with questions about the recall may contact Sally Vande Hei with American Foods Group at (920) 436-6523.

Consumers with food safety questions can phone the toll-free USDA Meat and Poultry Hotline at 1.-800-535-4555 The hotline can be reached from 10a.m. to 4p.m. (Eastern Time) Monday through Friday, and recorded food safety messages are available 24 hours a day.


Potencjalnie śmiercionośna Escherichia coli 0157H7 
w mielonym mięsie wołowym

(Bakterie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)

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December 6, 2000
Save-A-Lot Recalls Ground Beef

St. Louis, MO (SafetyAlerts) - Save-A-Lot Food Stores announced today that it has removed fresh ground beef from its company-owned stores in connection with a voluntary recall of ground beef initiated by American Food Groups, Inc. (AFG), a wholesale meat supplier based in Green Bay, Wis. Save-A-Lot has advised its licensees to do the same.

Save-A-Lot Food Stores operates nearly 900 stores in 36 states, stated it is taking the step as a precautionary action after the Minnesota Department of Health linked 22 cases of illness to E. coli bacteria in ground beef purchased in Minnesota.

Save-A-Lot is not aware of any illnesses associated with ground beef sold at its stores, nor does the company have stores in Minnesota.

For product safety and customer satisfaction, Save-A-Lot will offer full cash refunds to customers who return any ground beef that was purchased at Save-A-Lot from Nov. 1, 2000, to Dec. 4, 2000. To this end, the company is asking customers to check their freezers or refrigerators for any ground beef purchased from Save-A-Lot during that time frame.

The company stated in its press release it has  progressive programs in place to help ensure the quality and safety of meat products sold in its stores. Nonetheless, AFG's recall provides another reminder to consumers to practice safe handling, storage and cooking of ground beef as the best protection against food-borne illness.

Experts agree that ground beef is free of harmful bacteria once it has been cooked to 160 degrees Fahrenheit. In addition, consumers should keep cooked meat separate from unwashed plates or counters that held raw meat and remember to wash their hands thoroughly before and after handling raw foods.

Save-A-Lot is providing a 24-hour, toll free number to customers who may have concerns or questions about this voluntary recall. The phone number is 877-278-6454.


Zatajony aspartam w napojach firmy Dr. Pepper

(dawki E 951 w polskich produktach:
SUBSTANCJE SŁODZĄCE W ŻYWNOŚCI I NAPOJACH)

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December 6, 2000
Caffeine Free Dr. Pepper Recalled

Houston, TX (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Dr. Pepper Bottling Company of Houston is recalling certain Caffeine Free Dr. Pepper.  The product contains aspartame and high fructose corn syrup when it should only contain high fructose corn syrup.

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
Caffeine Free Dr. Pepper, in 12-ounce cans.

Recall #F-055-1.

CODE
H4H110155 through H4H110330 consecutively where last four digits represent military time of pack on August 11, 2000. code appears on bottom of can.

MANUFACTURER
Dr. Pepper Bottling Company of Houston, Houston, Texas.

RECALLED BY
Manufacturer, by visit starting on September 12, 2000.
Firm-initiated recall ongoing.

DISTRIBUTION
Texas.

QUANTITY
8,320 12-packs were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA


Listeria monocytogenes w produktach drobiowych
firmy Cargill Turkey Products

(Bakterie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)

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December 14, 2000
16.7 Million Pounds of Ready-To-Eat Poultry Products Recalled

Waco, TX (SafetyAlerts) - Cargill Turkey Products has announced it is recalling approximately 16.7 million pounds of ready-to-eat turkey and chicken products   produced at its Waco, Texas facility, the product may be contaminated with Listeria monocytogenes.

The products were produced from May 1 to December 11 and distributed nationwide through grocery stores, restaurants and institutions - and to Venezuela and Iceland.  The affected product is marked with the establishment number "P-635".

The Centers for Disease Control and Prevention (CDC) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) are studying whether some products from the Waco facility might contain Listeria monocytogenes associated with 25 cases of listeriosis, most of which have occurred since July 2000.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, pregnant women and individuals with weakened immune systems. Although healthy individuals may suffer short-term symptoms such as fever, headaches, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

Affected Product

Retail Sliced Packages: In 10 to12-ounce packages.

  • Owens's Hickory Smoked Pre-Sliced Turkey Breast, fresh
  • Plantation
    • Fiesta Pre-Sliced Turkey Breast, fresh
    • Mesquite Smoked Pre-Sliced Turkey Breast, fresh and frozen
    • Pre-Sliced Smoke banquet-style Turkey Breast, fresh and frozen
    • Black Forest Turkey Ham, fresh
    • Pre-Sliced Turkey Pastrami, fresh and frozen
    • Pre-Sliced Star Turkey Breast
  • Riverside
    • Pre-Sliced Hickory Smoked Turkey Breast, fresh and frozen
    • Pre-Sliced Oven prepared Turkey Breast, frozen
  • Honeysuckle White Pre-Sliced Oven Prepared Turkey, fresh and frozen
Un-sliced Products: For slicing or consumer sale whole.
  • Dine Rite Picnic Dark Turkey, fresh and frozen
  • Old South Turkey Ham, fresh
  • Plantation Cajun Fried Turkey, frozen
  • Honeysuckle White Cajun-Style Fried Whole Turkey, frozen
Wholesale: Products sold in bulk and sliced at delicatessens, restaurants, and institutions
  • Boar's Head:
    • Our Premium Low Salt Turkey, frozen
    • Golden Catering Skin-on Turkey Breast, fresh
    • Carmel Colored Our Premium Turkey Breast, fresh
    • Our Premium Low Salt Skinless Turkey Breast, fresh
    • Smoked Turkey Breast, fresh
    • Oil Browned Chicken Breast, fresh
    • Oven Prepared Skinless Turkey Breast, fresh
    • Smoked Chicken Breast, fresh
  • Other products were sold in bulk and would not be labeled at the point of purchase.
The Waco facility sold other products in bulk and that were sliced at delicatessens and restaurants and would not be readily identifiable by consumers. Cargill Turkey Products has contacted establishments who purchased those products, which are being removed and returned.

Consumers with questions about the recall may call Cargill Turkey Products at 888-621-2717 or visit the website www.plantation-foods.com. Cargill Turkey Products is based in Springdale, Ark., and is part of Minneapolis-based Cargill, Incorporated.


Fenylpropanolamina w stosowanych w przeziębieniach 
preparatach Triaminic firmy Novartis Consumer Health

(jakość i skład leków w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
ŚRODKÓW FARMACEUTYCZNYCH
I MATERIAŁÓW MEDYCZNYCH)

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December 14, 2000
Triaminic Cold Remedies Containing Phenylpropanolamine Withdrawn from the Market

Summit, NJ (SafetyAlerts) - Novartis Consumer Health Inc. has voluntarily withdrawn certain Triaminic cold remedies because they contain the decongestant, phenylpropanolamine.  Novartis has stated that this is not a mandatory recall, but a voluntary action to withdraw the products and replace them with reformulated products.

Last November, the Food and Drug Administration issued a nationwide warning against using over-the-counter drugs containing phenylpropanolamine.

The FDA stated that a recent study reported that taking phenylpropanolamine increases the risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is very low, FDA recommends that consumers not use any products that contain phenylpropanolamine. Click here to view the FDA warning.

The Triaminic cold remedies that have been with drawn are:
Cold & Allergy
Cold & Cough
Cough Relief
Expectorant Chest Congestion.

Novartis Consumer Health has stated that they have since reformulated these products with the decongestant pseudoephedrine.  Products containing pseudoephedrine are not affected by the withdraw.

Consumers who have purchased one of the above Triaminic products containing phenylpropanolamine should call Novartis Consumer Health at 1-800-548-3708 with the lot numbers on the box for a refund.


Bezpieczeństwo szczepionek powstałych przy wykorzystaniu materiałów pochodzenia bydlęcego; możliwość obecności prionów w szczepionkach firm: Aventis Pasteur, SmithKline Beecham, Chiron Behring, North American Vaccine, BioPort, Lederle Laboratories

Amerykański Urząd ds. Żywnosci i Leków (FDA) w 1993 i 1996 r. zwrócił się do wszystkich firm farmaceutycznych
o zaniechanie produkcji szczepionek powstałych przy wykorzystaniu materiałów pochodzenia bydlęcego, których źródłem są kraje, gdzie stwierdzono gąbczaste zwyrodnienie mózgu bydła (BSE) lub kraje, w których sytuacja w tym zakresie jest niepewna. Dochodzenie przeprowadzone w 2000r. ujawniło, że nie wszyskie firmy podporządkowały się zaleceniom FDA. Z końcem 2000r. sprawa dotyczyła następujących szczepionek:
- ActHIB - szczepionka przeciw Haemophilus influenzae typu b firmy Aventis Pasteur, S.A., sprzedawana też przez SmithKline Beecham Pharmaceuticals jako OmniHIB
- Certiva - szczepionka błoniczo-tężcowo-krztuśćcowa (DTaP) firmy North American Vaccine Inc.
- Infanrix - szczepionka błoniczo-tężcowo-krztuśćcowa (DTaP) firmy SmithKline Beecham Biologicals (w tym preparacie tylko anatoksyna błonicza wytwarzana przez Chiron Behring GmbH & Co. pochodzi z kraju występowania BSE)
- Havrix  - szczepionka przeciw wirusowemu zapaleniu wątroby typu A firmy SmithKline Beecham Biologicals

W przypadku niektórych innych szczepionek źródło materiałów pochodzenia bydlęcego jest nieznane, po części dlatego, że producenci albo nie prowadzili dokumentacji dotyczącej źródła takich materiałów albo nie mieli do niej dostępu, zwłaszcza w latach osiemdziesiątych i wczesnych dziewięćdziesiątych zanim po raz pierwszy zasugerowano związek pomiędzy BSE a nowym wariantem choroby Creutzfeldta - Jakoba. Do szczepionek zawierających materiał pochodzenia bydlęcego z niewiadomego źródła pozyskany w roku 1980 (obecnie szacuje się, że BSE pojawiło się po raz pierwszy w 1980r.) lub później należą:
- IPOL - inaktywowana szczepionka przeciw poliomyelitis  firmy Aventis Pasteur
- szczepionka przeciw wąglikowi firmy BioPort
- szczepionka przeciw wściekliźnie firmy BioPort
- PNU-IMUNE23 - szczepionka pneumokokowa firmy Lederle Laboratories

W Polsce zarejestrowane są m. in. następujące preparaty:

  • Havrix 1440 i Havrix 720 junior - szczepionka przeciw wirusowemu zapaleniu wątroby typu A firmy SmithKline Beecham
  • ActHIB - szczepionka przeciw Haemophilus influenzae typu b firmy Aventis Pasteur
  • IMOVAX POLIO - inaktywowana szczepionka przeciw poliomyelitis  firmy Aventis Pasteur i inne tej firmy:
  • PNEUMO 23 - szczepionka pneumokokowa firmy Aventis Pasteur
  • VACCIN RABIQUE szczepionka przeciw wściekliźnie Aventis Pasteur
  • IMOVAX RABIES VERO szczepionka przeciw wściekliźnie Aventis Pasteur
  • TOLLWUT-IMPFSTOFF MERIEUX szczepionka przeciw wściekliźnie Aventis Pasteur


(jakość i skład szczepionek w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
ŚRODKÓW FARMACEUTYCZNYCH
I MATERIAŁÓW MEDYCZNYCH)

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December 28, 2000

The Center for Biologics Evaluation and Research (CBER)
of the U.S. Food and Drug Administration (FDA)





MMWR Notice to Readers: PHS Recommendations for the Use of Vaccines
Manufactured with Bovine-Derived Materials

Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials

Bovine-derived materials have traditionally been used in the manufacture of many biological products, including vaccines. Bovine spongiform encephalopathy (BSE), so-called "mad-cow disease," was first recognized in the United Kingdom (UK) in the 1980s(1). The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has been concerned about eliminating any potential for contamination of biological products with the BSE agent This concern was heightened by the appearance of the human transmissible spongiform encephalopathy known as variant Creutzfeldt-Jakob Disease (vCJD, also referred to as new-variant CJD) in the UK in 1996; vCJD has been attributed, among other possibilities, to eating beef products from cattle infected with the agent of BSE (2). To date, there are no reports of BSE contamination of pharmaceutical or biological products. To minimize the possibility of contamination in such products, the FDA, in 1993 (published in the Federal Register on August 29, 1994, 59 FR 44591), and again in 1996, recommended that manufacturers not use materials derived from cattle that were born, raised, or slaughtered in countries where BSE is known to exist; the FDA referred manufacturers to the listing of such countries that is maintained by the U.S. Department of Agriculture (USDA)(3).

In 1991 the USDA list included only countries and other regions in which BSE was known to exist, such as France, Great Britain, Northern Ireland, the Republic of Ireland, Oman, and Switzerland. In 1998, the USDA expanded the list to include countries and other regions in which BSE had not been documented but in which import requirements were less restrictive than requirements that would be acceptable for import into the United States or in which surveillance was inadequate. Thus, all European countries, even those that have had no reported BSE cases, are currently on the USDA list, which is published in the Code of Federal Regulations, title 9, part 94 (9 C.F.R. part 94).

Earlier this year, CBER learned that its recommendations regarding the sourcing of bovine materials for the manufacture of vaccines had not been followed in at least one instance. As a result of this finding, CBER requested all vaccine manufacturers to review the source for all bovine-derived materials used in the manufacture of their vaccines. This review identified additional vaccines manufactured with bovine-derived materials that had been obtained from European countries on the USDA list.

No evidence exists that any case of vCJD has resulted from the administration of a vaccine product(4), and no cases of vCJD have been reported in the United States. To evaluate the risk of disease that might result from a vaccine manufactured with a process that utilizes bovine materials potentially contaminated with the BSE agent, CBER conducted risk assessments and convened a special joint meeting of the Transmissible Spongiform Encephalopathy Advisory Committee and the Vaccines and Related Biological Products Advisory Committee on July 27, 2000. In assessing the potential risk of vaccines, CBER and the joint Committees considered: (1) the likelihood that any cattle that were used might be infected (i.e., the time period and country of origin) and animal husbandry procedures; (2) the amount of bovine material that might be present in the final vaccine; and (3) the inherent infectivity of the various types of bovine materials that were used. The joint Committees concluded that the risk of vCJD posed by vaccines in the scenarios that were presented was theoretical and remote. They also noted that the benefits of vaccination far outweigh any remote risks of vCJD. The joint Committees made several recommendations.

  • Bovine-derived materials used in the routine production of vaccines that are sourced from countries on the USDA list should be replaced with bovine-derived materials from countries not on the USDA list.
  • Working bacterial and viral seed banks and working cell banks that were established using bovine-derived materials sourced from countries on the USDA list should be re-derived with bovine-derived materials from countries not on the USDA list. However, master bacterial and viral seed banks established in a similar manner do not need to be re-derived; the potential risk presented by the master seed banks is even more remote than that presented by the working seed banks and is outweighed by the risk of altering the bacterial or viral vaccine through re-derivation.
  • These issues are of public interest and, therefore, the public should be informed about the safety of vaccines that used materials sourced from countries on the USDA list, and the assessment of the nature of any risk of vCJD from such vaccines.
As noted above, there is no evidence that any case of vCJD has been caused by or is related to vaccines manufactured with bovine-derived materials obtained from countries in which BSE or a significant risk of BSE exists (i.e., countries on the USDA list), and thus the risk of vCJD is theoretical. The joint Committees’ recommendation to replace such bovine-derived materials with bovine-derived materials from countries not on the USDA list is a precautionary measure intended to minimize even the remote risk of vCJD from vaccines.

The vaccines that use bovine-derived materials from countries on the USDA list include: Aventis Pasteur, S.A.’s Haemophilus influenzae type b conjugate vaccine, ActHIB® (ActHIB® is also marketed as OmniHIB™ by SmithKline Beecham Pharmaceuticals); North American Vaccine Inc.’s diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, Certiva™ (the tetanus toxoid manufactured by Statens Seruminstitut for use in CertivaTM is the only component of the vaccine manufactured with bovine-derived materials from a country on the USDA list); SmithKline Beecham Biological’s DTaP vaccine, Infanrix®(the diphtheria toxoid manufactured by Chiron Behring GmbH & Co. for use in Infanrix® is the only component of the vaccine manufactured with bovine-derived materials from a country on the USDA list) and hepatitis A vaccine, Havrix®.

In some other cases, the source of the bovine-derived materials is unknown, in part because manufacturers have not always maintained or had access to records of the source of such materials, particularly in the 1980s and early 1990s, before the connection between BSE and vCJD was first suggested. Vaccines that use bovine-derived material of unknown origin obtained in 1980 or thereafter (the current best estimate is that BSE first emerged in 1980) include: Aventis Pasteur, S.A.’s inactivated polio vaccine, IPOL®; BioPort’s anthrax vaccine and rabies vaccine; Lederle Laboratories’ pneumococcal polysaccharide vaccine, PNU-IMUNE® 23.

Vaccines using bovine-derived materials from a country on the USDA list or from an unknown source to manufacture only the master seed are not listed above; the joint Advisory Committees indicated that master seeds need not be re-derived. Additional information on such vaccines can be obtained upon request.

The FDA has requested that manufacturers of vaccines using bovine-derived materials obtained from countries on the USDA list replace these materials with materials from countries not on the USDA list, consistent with the recommendations of the joint Advisory Committees. The manufacturers have agreed to fully implement these changes. Indeed, several manufacturers initiated a number of these changes before the July 27, 2000, joint Advisory Committee meeting. FDA anticipates that the majority of these changes will be completed within one year. The FDA will revise the list of vaccines using bovine-derived materials from countries on the USDA list or from an unknown source as the requested changes are implemented and the vaccines come to market.

The Public Health Service (PHS) recommends that all children and adults continue to be immunized according to current immunization schedules(5). At the present time, the PHS has no preference for using one licensed vaccine product over another based on the source of bovine-derived materials used in vaccine production. The recommendations of the FDA Advisory Committees and the actions of the FDA are, as described, precautionary and have been taken to reduce even the remote potential of a risk of vCJD and to maintain public confidence in the safety of vaccines. Failure to obtain the recommended vaccinations with licensed vaccines poses a real risk of serious disease.
 

References

  1. Wells G.A.H. et al. 1987. A novel progressive spongiform encephalopathy in cattle. Veterinary Record 121:419-420
  2. Spongiform Encephalopathy Advisory Committee of UK statement of 20 March 1996 (http://www.maff.gov.uk/animalh/bse/index.html)
  3. USDA 9 CFR part 94.18
  4. P. D. Minor, R.G. Will and D. Salisbury.2000. Vaccines and variant CJD Vaccine 19:409-410.

  5. http://www.cdc.gov/nip/recs/child-schedule.PDF; http://www.cdc.gov/nip/recs/adult-schedule.pdf

Transcripts of 27 July, 2000, Joint Transmissible Spongiform Encephalopathy and Vaccines and Related Biologicals Products Advisory Committees

On July 27th, 2000 the Center for Biologics Evaluation and Research (CBER) convened a special joint meeting of the Transmissible Spongiform Encephalopathy and the Vaccines and Related Biological Products Advisory Committees. The purpose of the joint meeting was to ask these committees to consider the potential risks and possible actions that should be taken with regard to licensed and investigational vaccine that contain bovine derived material sourced from countries on the current USDA list of BSE-risk countries. The transcripts of this meeting and copies of the briefing materials provided to the committee members can be found at: http://www.fda.gov/ohrms/dockets/ac/cber00.htm

CBER and FDA Guidance on Sourcing of Bovine Derived Raw Materials

Letters to manufacturers and other guidance documents are part of the mechanism by which regulated industry and the public are informed about safety issues and expectations of the FDA regarding the development, testing and licensure of vaccines. Although these documents do not have the force of law they do represent the current thinking of the agency on licensure and control of FDA regulated products.

The following is a summary of the guidance documents and letters from FDA and CBER which relate to the potential for contamination of products with the agent that causes BSE.

  1. Points to Consider in the Characterization of Cell LInes Used for the Production of Biologics

  2. In a letter to manufacturers in July 1993 CBER asked manufacturers to review the May 1993 revision of the 1987 document "Points to Consider in the Characterization of Cell Lines Used for the Production of Biologics". In the revised version of this document CBER indicated that manufacturers should be able to provide detailed information on cell culture history, isolation, media, identity, and adventitious agent testing of cell lines used in the production of biological products.
  3. Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use

  4. In September 1997 following an April 1997 TSE advisory committee review FDA issued a guidance document for industry addressing the sourcing and processing of gelatin to reduce the potential risk of transmission of BSE through FDA-regulated products for human use.
  5. Letter to Manufacturers of Biological Products: Recommendations Regarding Bovine Spongiform Encephalopathy

  6. In April 2000 CBER sent a letter to manufacturers requesting that ruminant derived material from Europe not be used in the manufacture of FDA-regulated products for humans.

Vaccines and Vaccinations

For more information on the US vaccination program and on vaccine preventable disease, please visit the following web sites:
    CDC - Public Health Achievements

    Achievements in Public Health, 1900-1999 Impact of Vaccines Universally Recommended for Children -- United States, 1990-1998

    CDC - National Immunization Program

Current list of vaccines using bovine-derived materials from countries on the USDA's BSE list

Vaccines that use bovine-derived materials from countries on the USDA list include:
  1. Aventis Pasteur, S.A.’s Haemophilus influenzae type b conjugate vaccine, ActHIB® (ActHIB® is also marketed as OmniHIB™ by SmithKline Beecham Pharmaceuticals)
  2. North American Vaccine Inc.’s diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, Certiva™
  3. SmithKline Beecham Biological’s DTaP vaccine, Infanrix®
  4. SmithKline Beecham Biological’s Hepatitis A vaccine, Havrix®.
Vaccines that use bovine-derived materials of unknown geographical origin include:
  1. Aventis Pasteur, S.A.’s inactivated polio vaccine, IPOL®
  2. BioPort’s Anthrax vaccine
  3. BioPort’s Rabies vaccine
  4. Lederle Laboratories’ Pneumococcal polysaccharide vaccine, PNU-IMUNE® 23.
1This information will be periodically updated to reflect the most current status.

Last Updated: 12/28/2000
 


sytuacja w Polsce

"NEW YORK TIMES", February 8, 2001
5 Drug Makers Use Material With Possible Mad Cow Link
tekst na naszej stronie


Listeria monocytogenes w produktach drobiowych firmy Cargill Turkey Products
(Bakterie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)

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January 3, 2001
Cargill Turkey Recall Expanded

Waco, TX (SafetyAlerts) - Cargill Turkey Products has added approximately 195,000 pounds of "HoneySuckle White Hickory Smoked Turkey Ham" to the list of ready-to-eat poultry products recalled on December 14, 2000. The products, produced at Cargill’s facility in Waco, Texas, may be contaminated with Listeria monocytogenes.

The "HoneySuckle White Hickory Smoked Turkey Ham," fresh, was distributed to retail establishments in Colorado, Kansas, Louisiana, Massachusetts, Michigan, Ohio, Pennsylvania, Tennessee, Texas, and Wisconsin, and to institutions in Minnesota.

The product was produced from May 1 to December 11, 2000 and is marked with the establishment number "P-635." A "Use or freeze by" date of "02 26 1W" (indicating Feb. 26, 2001) or earlier is on the package.

Cargill Turkey Products recalled 16.7 million pounds of ready-to-eat poultry products on Dec 14 for possible Listeria monocytogenes contamination after state health departments reported illnesses to the Centers for Disease Control and Prevention. FSIS and the CDC are currently studying these illnesses. Anyone concerned about an illness should contact a physician.

"Because of the potential for foodborne illness, we urge consumers to check to see if they have purchased any of these products," said Thomas J. Billy, FSIS administrator. "If they find the recalled products, consumers should not eat them, but return them to the point of purchase. Consumers may also wish to ask delis and restaurants if purchased products are subject to the recall."

Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease. Healthy people rarely contract listeriosis. Listeriosis can cause high fever, severe headache, neck stiffness, and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as serious and sometimes fatal infections in those with weak immune systems--infants, the frail or elderly, and persons with chronic disease, with HIV infection, or taking chemotherapy.

Consumers with questions about the recall may contact Cargill Turkey Products at (888) 621- 2717, 24 hours a day, seven days a week. Information is also available on the company’s website at http://www.plantation-foods.com or at http://www.honeysucklewhite.com. Media with questions may contact Mark Klein, Cargill communication manager, at (952) 742–6211. Media with questions about illnesses can contact the CDC press office at (404) 639-3286.

Consumers with food safety questions can phone the toll-free USDA Meat and Poultry Hotline at 1-800-535-4555. The hotline can be reached from 10 a.m. to 4 p.m. (Eastern Time) Monday through Friday, and recorded food safety messages are available 24 hours a day.

Updated complete list of products subject to recall:

The sliced products that consumers may have purchased at retail are:
 

  1. Owen’s Hickory Smoked Pre-Sliced Turkey Breast, fresh
  2. Plantation
    • Fiesta Pre-Sliced Turkey Breast, fresh
    • Mesquite Smoked Pre-Sliced Turkey Breast, fresh and frozen
    • Pre-Sliced Smoke Banquet-style Turkey Breast, fresh and frozen
    • Black Forest Turkey Ham, fresh
    • Pre-Sliced Turkey Pastrami, fresh and frozen
    • Pre-Sliced Star Turkey Breast
  3. Riverside
    • Pre-Sliced Hickory Smoked Turkey Breast, fresh and frozen
    • Pre-Sliced Oven Prepared Turkey Breast, frozen
  4. Honeysuckle White Pre-Sliced Oven Prepared Turkey, fresh and frozen
Unsliced products include:
     
  1. HoneySuckle White Hickory Smoked Turkey Ham, fresh
  2. Dine Rite Picnic Dark Turkey, fresh and frozen
  3. Old South Turkey Ham, fresh
  4. Plantation Cajun Fried Turkey, frozen
  5. Honeysuckle White Cajun-Style Fried Whole Turkey, frozen
The following products may have been distributed at deli counters, restaurants or institutions:
     
  1. Boar’s Head
    • Our Premium Low Salt Turkey, frozen
    • Golden Catering Skin-on Turkey Breast, fresh
    • Carmel Colored Our Premium Turkey Breast, fresh
    • Our Premium Low Salt Skinless Turkey Breast, fresh
    • Smoked Turkey Breast, fresh
    • Oil Browned Chicken Breast, fresh
    • Oven Prepared Skinless Turkey Breast, fresh
    • Smoked Chicken Breast, fresh.
Other products were sold in bulk and would not be labeled at the point of purchase.

Zatajone orzechy ziemne w produktach firmy Wegmans

(NIEPOŻĄDANE REAKCJE NA PRODUKTY SPOŻYWCZE)

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January 3, 2001
Allergy Alert: Wegmans Recalls Krinkle Cut Chips

Rochester, NY (SafetyAlerts) - Wegmans Food Markets, Inc. has announced a recall of its Wegmans Krinkle Cut Potato Chips, packaged in 13.5 oz. and 5.5 oz bags.  The affected product is marked with "Sell by" dates of JAN 0901A3 and FEB0101A5. These products may contain undeclared peanuts.

The products are sold at Wegmans Food Markets in New York, New Jersey, and Pennsylvania.

Consumers with questions can contact Wegmans at 1-800-WEGMANS.



Zatajone migdały i pszenica w produktach firmy Kellogg
(NIEPOŻĄDANE REAKCJE NA PRODUKTY SPOŻYWCZE)
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January 3, 2001
Allergy Alert: Kellogg Co. Recalls Frosted Flakes

Battle Creek, MI (SafetyAlerts) - Kellogg USA has announced a recall of its 20 oz. Kellogg's Frosted Flakes cereal with a carton number of K0152E, and a Better If Used Before Date of OCT 03 2001 KMA101 printed on the top of the package. The product may contain another Kellogg product that contains almonds and wheat.

While the product is not harmful to the general public, it could cause serious and potentially fatal side effects to those whohave an allergy to these ingredients.

The product was distributed nationwide.

Consumers can call Kellogg Company toll-free at 1-877-875-3182 for a replacement coupon.



 

Śladowe ilości kwasu arystocholowego
w Neo Concept Aller Relief firmy BMK International

(jakość i skład leków w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
ŚRODKÓW FARMACEUTYCZNYCH 
I MATERIAŁÓW MEDYCZNYCH)

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January 22, 2001
Neo Concept Aller Relief Recalled

Wellesley, MA (SafetyAlerts) - BMK International said today it is voluntarily recalling Neo Concept Aller Relief after receiving notification from the FDA that the product contains trace amounts of aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. Products that contain arstolochic acid have been associated with several occurrences of kidney failure in Europe. The use of aristolochic acid containing products has also been linked to the increase risk of kidney cancer in people who have consumed it.

Aller Relief was distributed nationwide to licensed health care practitioners, and retail outlets. Aller Relief is packaged in 30-ct. and 90-.ct. capsules. The lot numbers covered in this recall are 30-ct. and 90-ct.: #003480, #0006480.

No complaints or reports illnesses have been reported to date.

The recall is a result of the FDA notification that recommended manufacturers test their products that contain herbs that may be contaminated with aristolochic acid. The company was informed by the FDA that the product contains trace amounts of aristolochic acid and thus is conducting a voluntary recall. The company has reformulated the Aller Relief product to ensure that in the future no herb in the formula contains or may be adulterated with aristolochic acid. The reformulated product will available shortly.

Consumers with questions can call telephone: (781) 235-9999. Consumers should return the product to the place of purchase for a full cash refund.


Transgeniczna kukurydza w produktach firmy Scott’s Auburn M
(WPŁYW ŻYWNOŚCI TRANSGENICZNEJ 
NA ŚRODOWISKO I ZDROWIE CZŁOWIEKA

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January 25, 2001
Enriched Scott's Brand Pearl Plain Yellow Corn Meal Recalled

Auburn, KY (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Scott’s Auburn Mills is recalling Enriched Scott's brand Pearl Plain Yellow Corn Meal because the products appear to contain the genetic material (DNA) necessary for the production in corn (trade name: StarLink) of the pesticide Cry9C protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not allowed for use in foods for human consumption.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Enriched Scott's brand Pearl Plain Yellow Corn Meal in 50 lb. bags.

Recall #F-174-1.

CODE:
Lot 348.

MANUFACTURER:
Scott’s Auburn Mills, Inc., Auburn, KY.

RECALLED BY:
Manufacturer, by fax and mail on January 11, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
Illinois.

QUANTITY:
25-50 lb. bags

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
 


Pleśnie w 100% soku pomarańczowym firmy Welch’s

(Pleśnie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)

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January 25, 2001
16 Ounce Bottles of Welch’s 100% Orange Juice Recalled

First public notice issued by FDA of 'completed recall'...

Concord, MA (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Welch’s is recalling Welch’s 100% Orange Juice, in 16 fl. oz. plastic bottles, because the product unfit for food due to mold contamination.

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
Welch’s 100% Orange Juice in 16 fl. oz. Plastic bottles.

Recall #F-164-1.

CODE:
Lot OV26G

MANUFACTURER:
Krier Foods, Inc., Random Lake, WI.

RECALLED BY:
Welch’s, Concord, MA, by email and fax on October 3, 2000. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
Nationwide.

QUANTITY:
3854 cases (24 bottles per case).

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Pleśnie w napojach firmy Coca-Cola
(Pleśnie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)

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Twoje prawo 
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January 25, 2001
Green Squall Flavor POWRADE Recalled

First public notice issued by FDA of 'completed recall'...

Atlanta, GA (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Coca-Cola USA Operations is recalling Green Squall flavor POWRADE because the product unfit for food due to mold contamination.

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
Green Squall flavor POWRADE beverage in 20 oz. Plastic bottles.

Recall #F-171-1.

CODE:
MAY1401MDD

MANUFACTURER:
The Minute Maid Co. for Coca-Cola USA at Coca-Cola Bottling Co. of Chicago, Niles, IL.

RECALLED BY:
Coca-Cola USA Operations, Atlanta, GA, by email and fax December 8, 2000. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION
Nationwide.

QUANTITY
13,730 cases (24 bottles per case).

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Farba bez certyfikatu w tajskich produktach firmyVasinee Food Corp.

(dawki E 102 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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January 25, 2001
Longevity Noodles Recalled

First public notice issued by FDA of 'completed recall'...

Brooklyn, NY (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Vasinee Food Corp. is recalling Longevity Noodles because the product contains the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5).

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Longevity Noodle in 1 lb. Plastic bags.

Recall #F-163-1.

CODE:
None. All product on the market at the time the recall was initiated was affected.

MANUFACTURER:
Wang Derm Exporters Ltd. Part., Bangkok, Thailand

RECALLED BY:
Vasinee Food Corp., Brooklyn, NY (importer), by letter on August 18, 2000. **Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
New York, Pennsylvania, Rhode Island, Massachusetts.

QUANTITY:
200 cases (25-1 lb. Packages per case).

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
 


Farby bez certyfikatu w chińskich produktach firmyAllied Imports, Inc.

(dawki E 102 i E 110 w polskich produktach: 
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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January 25, 2001
Allied Imports Recalls Orange Jelly Packages

First public notice issued by FDA of 'completed recall'...

Brooklyn, NY (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Allied Imports, Inc. is recalling Orange Jelly packages because the product did not bear an ingredient statement in English and it contains the uncertified color additives tartrazine (certifiable as FD&C Yellow No.5), and sunset yellow FCF (certifiable as FD&C Yellow No. 6).

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Orange Jelly packages in a rigid plastic cup with a foil seal, net wt. 30 grams.

Recall #F-165-1.

CODE:
Best before 10 09 2000.

MANUFACTURER:
Xinhui Foodstuffs Imp. & Exp. Company of Guangdong, Xinhui City Guangdong, China.

RECALLED BY:
Allied Imports, Inc. Brooklyn, NY (importer), by telephone July 28, 2000. **Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
New York.

QUANTITY:
14 cases (11 lbs. of packages per case).

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Zatajona farba w produktach firmy A Millner Corp.

(dawki E 102 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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January 25, 2001
Albert's Greek Pepperocini Peppers Recalled

First public notice issued by FDA of 'completed recall'...

Bethlehem, PA (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that A Millner Corp. is recalling Albert's Greek Pepperocini Peppers because the product contained undeclared FD&C Yellow No. 5.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Albert's Greek Pepperocini Peppers in 15.5 oz. containers.

Recall #F-166-1.

CODE:
573531

MANUFACTURER:
A Millner Corp., Bethlehem, PA.

RECALLED BY:
Manufacturer, by letter on September 15, 2000. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
Nebraska.

QUANTITY:
100 cases (12 -15.5 oz. Containers per case).

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
 


Zatajone farby w produktach firmy Sinton’s Dairy Food Company LLC
(dawki E 102 i E 110 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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January 25, 2001
Sinton’s Dairy Food Co. Recalls Ice Milk Mixes

First public notice issued by FDA of 'completed recall'...

Colorado Springs, CO (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Sinton’s Dairy Food Company LLC is recalling Ice Milk Mixes because the products contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Ice Milk Mixes. Recall numbers:
Recall # F-167-1, 14% Premium Mix, 2.5 gallons
Recall # F-168-1,, Cone Ice Milk Mix, Chocolate, ˝ gallon
Recall # F-169-1, Shake Ice Milk Mix, Vanilla, ˝ gallon
Recall # F-170-1, Cone Ice Milk Mix, Vanilla ˝ gallon

CODE:
All product distributed prior to August 11, 2000.

MANUFACTURER:
Sinton’s Dairy Food Company LLC, Colorado Springs, CO.

RECALLED BY:
Manufacturer, by telephone on August 11, 2000, followed by letter. Firm-initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
Colorado.

QUANTITY:
209,773 units.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Wytworzone w antysanitarnych warunkach mleko w proszku
 w produktach m. in. firm Cadbury-Wedel i Jutrzenka

(wymagania sanitarne dla polskich produktów:
POLSKIE PRZEPISY SANITARNE 
DOTYCZĄCE ARTYKUŁÓW SPOŻYWCZYCH)

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 31. stycznia, 2001

TVP1, TVN - od listopada ub. r. policja obserwowała działalnosć nielegalnej wytwórni mleka w proszku we Włocławku. W ciągu półtora roku firma wyprodukowała w antysanitarnych warunkach  250 ton składnika wyrobów cukierniczych, w tym czekolad mlecznych i pieczywa cukierniczego.

Red. Przemysław Orcholski "WIADOMOSCI" TVP1: "..policjanci, gdy weszli tu po raz pierwszy, byli zaskoczeni, że w takich warunkach można produkować i magazynować cokolwiek do jedzenia,. Z dokumentów firmy wynika jednak, że ta fabryczka miała odbiorców w całym kraju. Do kontrahentów nielegalnej wytwórni należą nawet największe w Polsce firmy produkujące słodycze. Jeśli pochodzące stąd mleko było skażone Salmonellą, gronkowcem, albo innymi bakteriami lub grzybami, to znaczy, że wciąż jesteśmy narażeni na zjedzenie go w markowych czekoladkach lub ciastach. Mleko w proszku jest bowiem używane do produkcji wyrobów czekoladowych. Nieoficjalnie od pracowników sanepidu, którzy badają proszek, dowiedzielismy się, że mleko produkowane w takich warunkach nie może odpowiadać normom obowiązującym w polskim przemysle, jest bowiem skażone co najmniej bakteriologicznie. Jesli badania potwierdzą te przypuszczenia, to własciciel nielegalnej fabryki może trafić do więzienia nawet na 8 lat."

Red. Mirosław Rogalski  "FAKTY" TVN - "Aż trudno uwierzyć, że takiemu dostawcy zaufały tak duże firmy jak warszawski Wedel, czy bydgoska Jutrzenka. Obiorcy fałszywego mleka tłumaczą się, że miało ono certyfikat jakosci wystawiony przez podejrzaną firmę Avamilk, poddane też było wewnętrznym kontrolom i co najważniejsze, spełniało też wymogi sanitarno-higieniczne. (Agnieszka Surowicz, CADBURY WEDEL: "Mamy własne laboratorium, które przeprowadza analizy wszelkich surowców, które są przyjmowane do produkcji. Jeżeli nasze laboratororium nie wykazało żadnych niezgodnosci, to ten surowiec został dopuszczony do produkcji"). Może się okazać, że mleko w proszku i owszem było nieszkodliwe, ale nie wybaczalne jest, że odbiorcy, renomowani producenci słodyczy, nie sprawdzili od kogo kupują towar.."

wystąpienie do Głównego Inspektora Sanitarnego
ws potrzeby wycofania z obrotu produktów powstałych w oparciu o składnik,
który może zagrażać zdrowiu i życiu konsumentów


Transgeniczna kukurydza
w produktach firmy Minsa Corporation
(WPŁYW ŻYWNOŚCI TRANSGENICZNEJ
NA ŚRODOWISKO I ZDROWIE CZŁOWIEKA

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January 31, 2001
Minsa Corp. Recalls Yellow Corn Flour Masa

First public notice issued by FDA of 'completed recall'...

Muleshoe, TX (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Minsa Corporation is recalling Yellow Corn Flour masa  because the product tested positive for StarLink.
 Starlink
Pesticide Name: Bacillus thuringiensis subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for Its Production in Corn

Trade and Other Names: StarLink™

OPP Chemical Code: 006466

Pesticide Type: Insecticide

The pesticide is not allowed for use in foods for human consumption.
 This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Yellow Corn Flour masa to make taco shells, tortillas, tortilla chips, corn chips, and taquitos. Labeling for all bags are stated in part:
"***Minsa***STONE GROUND CORN MASA***Instant Corn Masa Floour***MINSA CORPORATION P.O. BOX 484, MULESHOE, TEXAS 79347***.

"For each of the following products the product number is hand written on bags that is used for varioous products and the additional labeling is stated in part,
Taco 1, 6992 "***TACO SHELL #1***"
Tortilla 2Y, 6993 "***TORTILLA***"
Tortilla 2Y0, 6994 "***TORTILLA***"
Corn Chip 8, 6995 "***CORN CHIP***"
Tortilla Chip 1Y,6998 "***TORTILLA CHIP 1Y***"
Taco 6F, 6999 "***TACO #6F***"
Taco 6NF, 7000 "***TACO SHELL***"
Taquito 7001 "***TAQUITO***"
Tortilla Chip 1Y, 7007 "***TORTILLA CHIP 1Y***"
Tortilla Chip 6Y, 7008 "***TORTILLA CHIP***"
Tortilla Chip 5S, 7009 "***TORTILLA CHIP***"
Corn Chip 6, 7010 "***CORN CHIP***"
Tortilla 3Y 7012 "***TORTILLA***"
Tortilla 3YS, 7013 "***TORTILLA 3YS***"
Taco 1 7014 "***TACO SHELL #1***"
Taco 6NF 7016 "***TACO SHELL***"
Taco 6NF 7017 "***TACO SHELL***".

Recall #F-185-1.

CODE:
The following codes of Yellow corn flour are being recalled:
Taco 1, 6992;
Tortilla 2Y, 6993;
Tortilla 2Y0, 6994;
Corn Chip 8, 6995;
Tortilla Chip 1Y, 6998;
Taco 6F, 6999;
Taco 6NF, 7000;
Taquito 1, 7001;
Tortilla Chip 1Y, 7007;
Tortilla Chip 6, 7008;
Tortilla Chip 55, 7009;
Corn Chip 6, 7010;
Tortilla 3Y, 7012;
Tortilla 3YS, 7013;
Taco 1, 7014;
Taco 6NF, 7016;
Taco 6NF, 7017.

MANUFACTURER:
Minsa Corporation, Muleshoe, TX .

RECALLED BY:
Manufacturer, by letter on November 6, 2000. Firm initiated recall **complete.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
Nationwide.

QUANTITY:
56,045 x 50 lb. bags of the 17 various corn mix products.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Niedozwolona farba E 124 w chińskich produktach firmy Well Luck Co. Inc

(dawki E 124 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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January 31, 2001
Well Luck Co. Recalls Super Plum and Red Bean & Rice Jelly Ice Bars

First public notice issued by FDA of 'completed recall'...

Jersey City, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Well Luck Co. Inc is recalling Red Bean and Rice Jelly Ice Bars and Super Plum Ice Bars because the product contains an unpermitted color - Ponceau 4R.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
a) Red Bean and Rice Jelly Ice Bar.
Recall #F-188-1;
b) Super Plum Ice Bar.
Recall # F-189-1.

CODE:
None. All product containing the unapproved color additive Ponceau 4R is under recall.

MANUFACTURER:
G-Jet Enterprise Co, Sunchung, Taiwan Rep.of China.

RECALLED BY:
Well Luck Co., Inc, Jersey City, NJ. by letter dated 10/9/2000. Firm- initiated recall, **complete. Problem identified by New York State Division of Agriculture and Markets.

**Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
Nationwide.

QUANTITY:
350 ctn x 6 bars of Ice Bar Red Bean; 200 ctn x 6 bar of Ice Bar Super plum.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Salmonella typhimurium w produktach firmy Dole

(Bakterie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)

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February 3, 2001
Dole Recalls Cole Slaw

Westlake Village, CA (SafetyAlerts) - Dole Fresh Vegetables Inc. has issued an alert to consumers not to consume certain packages of Dole Cole Slaw distributed by Dole Fresh Vegetables Inc., Salinas, Calif. 93902. One package was found by Inspectors from the New York Department of Agriculture and Markets to indicate the presence of Salmonella.

No illness resulting from the consumption of this product has been reported.

The cole slaw is packaged in a 16 ounce "pillow type" plastic film with the code "BEST IF USED BY 02 05 01 CO1722A." No other lots of product are affected.

Inspectors from the Department of Agriculture and Markets sampled the product at a Westchester County retail food store during a routine inspection. Laboratory analysis indicated the presence of Salmonella typhimurium.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience symptoms similar to a bad case of the flu.

Consumers are urged to check if they have this product with this code date and to discard the product or return it to the place of purchase for a full refund or substitute product.

Consumers with questions may contact the Dole Consumer Information Center at 800/356-3111.


Niedozwolona farba E 124 w chińskich produktach firmy Strong America Ltd.
(dawki E 124 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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February 8, 2001
Loquat Slice Recalled by New Yor Firm

First public notice issued by FDA of 'completed recall'...

Brooklyn, NY (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Strong America Ltd., is recalling - or has recalled - Loquat Slice in flexible plastic packages because the product contains Ponceau 4R , an unapproved color additive.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT:
Loquat Slice in flexible plastic packages, net wt. 3.5 oz. (98 g), 50 packages per case. Ingredients: Sugar, Salt, Loquat. Product of China.

Recall #F-204-1.

CODE:
Product bears barcode 998118 823938 & no other coding.

MANUFACTURER:
Shan Dong Zhaoyuan Huatuan Fruit Co., Shan Dong City, China.

RECALLED BY:
Strong America Ltd., Brooklyn, NY (Importer & distributor),by letter on May 10, 2000. *Completed recall resulted from sample analysis and follow-up by the New York State Dept. of Agriculture & Markets (NYSDAM).

*Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
NY, CT, MA, NJ, IL, OH, PA, and Washington DC.

QUANTITY:
15 cases (50 - 3.5 oz. packages per case).

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Niedozwolona farba E 124 i zatajona farba E 102
w chińskich produktach firmy East Park Trading Inc.

(dawki E 124 i E 102 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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February 8, 2001
Yolk Juice Bun and Peach Shaped Bun Recalled

First public notice issued by FDA of 'completed recall'...

Brooklyn, NY (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that East Park Trading Inc. is recalling - or has recalled - Yolk Juice Bun and Peach Shaped Bun because both products contain the unapproved color additive Ponceau 4R. In addition, the Yolk Juice Bun contains the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5).

This is the first public notice of this Class II recall issued by FDA.

PRODUCT:
a) Yolk Juice Bun packed in rigid plastic containers w/cellophane overwrap, net wt. 240 grams. Made in China.
Recall #F-202-1.
b)Peach Shaped Bun packed in rigid plastic containers w/cellophane overwrap, net wt. 350 grams. Made in China.
Recall #F-203-1.

Firm on labels - Guangzhou Restaurant Enterprises Group Likofu Food Co. Ltd.

CODE:
All codes including Q/(GZ)GZJJ4.

MANUFACTURER:
Guangzhou Restaurant Enterprises Group Likofu Food Co. Ltd.Guangzhou, China.

RECALLED BY:
East Park Trading Inc., Brooklyn, NY (Importer & distributor), by telephone on 6/8/00. *Completed recall resulted from sample analysis and follow- up by the New York State Department of Agriculture and Markets.

*Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
New York, NY.

QUANTITY:
Yolk Juice Buns: 100 cases (24 - 240 gram packages per case) were distributed; Peach Shaped Buns: 9 cases (28 - 350 gram packages per case) were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


Zanieczyszczona woda w pojemniku firmy Safeway Inc.

(wymagania sanitarne dla polskich produktów:
POLSKIE PRZEPISY SANITARNE DOTYCZĄCE WODY)

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February 8, 2001
Safeway Drinking Water and Purified Water Recalled

First public notice issued by FDA of 'completed recall'...

Pleasanton, CA (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Safeway Inc.  is recalling - or has recalled - Safeway brand drinking water and Safeway brand purified water because the products are unfit for food since they contain particulate matter.

This is the first public notice of this Class III recall issued by FDA.

PRODUCTS:
a) Safeway brand drinking water, one gallon (3.78L) clear plastic bottle with blue plastic cap, labeled in part: "SAFEWAY DRINKING drinking water
*** 1 GALLON (3.78) *** DISTRIBUTED BY SAFEWAY INC. P.O. BOX 99,
PLEASANTON, CA 94566-0009 PRODUCT OF U.S.A. ***".
Recall # F-200-1.

b) Safeway brand purified water, 1 gallon (3.78L) clear plastic bottle with red plastic cap, labeled in part: "SAFEWAY PURIFIED purified water
*** 1 GALLON (3.78L) *** DISTRIBUTED BY SAFEWAY INC. HEAD OFFICE: OAKLAND, CA 94660 PRODUCT OF U.S.A. ***".
Recall #F-201-1.

CODE:
Both products were identified with the code that reads
---"BEST BEFORE FEB 4"

MANUFACTURER:
Safeway Bottled Water Division, Tempe, Arizona.

RECALLED BY:
Safeway Inc., Pleasanton, California, by e-mail, on August 15, 2000. Firm-initiated recall *complete.

*Completed recall: While the FDA has completed processing of this particular recall, it does not mean this particular product has been fully accounted for.

DISTRIBUTION:
Arizona and New Mexico.

QUANTITY:
The firm shipped 7,560 cases of purified water and 23,100 cases of drinking water. All products are sold in cases of six gallon bottles each.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
 


Zatajona farba w produktach firmy Asia Trans & Co., INC.

(dawki E 129 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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February 8, 2001
Redbug Brand Dried Shrimp in 1 lb. Packages Recalled

Kailua-Kona, HI (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Asia Trans & Co., INC. is recalling Redbug Brand Dried Shrimp in 1 lb. Packages because the product contains undeclared FD&C Red #40.

This is the first public notice of this Class III recall issued by FDA.

PRODUCT:
Redbug Brand, Dried Shrimp in 1 lb. Packages.

Recall #F-197-1.

CODE:
No Codes.

MANUFACTURER:
Blum & Bergeron, INC., Houma, LA.

RECALLED BY:
Asia Trans & Co., INC., Kailua-Kona, HI., by telephone on 1/02/01. FDA-initiated recall ongoing.

DISTRIBUTION:
Island of Hawaii.

QUANTITY:
100 LBS.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.


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ALARM KONSUMENCKI 
- FIRMY, MARKOWE PRODUKTY, ZAGROŻENIA ZDROWIA- CZ. III
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wystąpienie do Głównego Inspektora Sanitarnego
ws potrzeby wycofania z obrotu produktów powstałych w oparciu o składnik,
który może zagrażać zdrowiu i życiu konsumentów:

Wystąpienie wysłano pocztą 6. 02. 2001. Z powodu braku reakcji do 28. 02. 2001 dostarczono je ponownie, składając w sekretariacie GIS za potwierdzeniem odbioru. Dotychczas nie uzyskano ani postulowanych działań, ani odpowiedzi na wystąpienie. Bezczynność ówczesnego Głównego Inspektora Sanitarnego w tej sprawie była taka sama, jak w przypadku zalewu polskiego rynku produktami koncernów agrochemicznych zawierającymi zatajone składniki genetycznie zmodyfikowane i w świetle dokumentów - akceptowana przez rząd.



 
 

(................................)
Alarm konsumencki
ALARM KONSUMENCKI
 
 
 



BAZA INFORMACJI PRAWNEJ I NORMALIZACYJNEJ
aktualne warunki użytkowania

<<<SYNTEZA INFORMACJI W PRZYGOTOWANIU>>>


DOKUMENTACJA ZAGROŻEŃ ZDROWIA W POLSCE
aktualne warunki użytkowania

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M
C
K
alergie, zatrucia, zakażenia, urazy
dochodzenie przyczyn  w składzie: 
żywności, napojów, kosmetyków, leków
i innych produktów,
w usługach oraz w otaczającym środowisku

PORADNIA 
MEDYCZNEGO CENTRUM KONSUMENTA
 

M
C
K

 
 
§
§
§
§
§
kto wytwarza lub sprzedaje produkt niebezpieczny, ten odpowiada
za ciężki uszczerbek na zdrowiu, inne naruszenie czynności narządu ciała lub rozstrój zdrowia, a także za doznaną krzywdę konsumenta

Naprawienie szkody obejmuje wszelkie wynikłe z tego powodu koszty 
Na żądanie poszkodowanego zobowiązany do naprawienia szkody powinien  wyłożyć z góry sumę potrzebną na koszty leczenia, a jeżeli poszkodowany  stał się inwalidą, także sumę potrzebną na koszty przygotowania do innego  zawodu. Jeżeli poszkodowany utracił całkowicie lub częściowo zdolność do  pracy zarobkowej albo jeżeli zwiększyły się jego potrzeby lub zmniejszyły  widoki powodzenia na przyszłość, może on żądać od zobowiązanego do  naprawienia szkody odpowiedniej renty. Jeżeli w chwili wydania wyroku szkody nie da się dokładnie ustalić, poszkodowanemu może być przyznana renta tymczasowa.

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MEDYCZNE CENTRUM KONSUMENTA
 



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