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
IV
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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Kwas arystolochowy w chińskich produktach ziołowych

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

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April 11, 2001
FDA First Notice: Mayway Corp. Recalls 5 Chinese Herb Products

Oakland, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Mayway Corp. has recalled 5 Chinese herb products because they contain aristolochic acid, a potent carcinogen and nephrotoxin.

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

PRODUCTS
a) Temple of Heaven Brand Chinese Herbs, Top Grade, Radix Aristolochiae, Net Wt. 16 oz. (1 lb.). Recall #F-334-1;

b) Plum Flower Brand, Sulphur Free - Chlorine Free - Aluminum Phosphate Free, Ma Dou Ling, Aristolochia, MW# 5344, Net. Wt. 250g (8.83 oz.).
Recall #F-335-1;

c) Chinese Herb Frucutu Aristolochiae Net Wt. 16 oz. (1 lb.). Recall #F-336-1;

d) Plum Flower, Fructus Aristolochiae, Herbal Extract Powder, Net Wt. 3.5 oz. (100g). Recall #F-337-1;

e) Plum Flower Brand Single Herb Extract Full Spectrum 5:1 Herb Extract Powder, Ma Dou Ling, Aristolochia Debilis Fruit, MW# 5344C, Net Wt 3.5 oz. (100 g). Recall #F-338-1.

CODE:
All Codes.

MANUFACTURER:
a) Sam Luen Co., Hong Kong, b) Anguo MeiWei Medicinal Herbs, Anguo, China, c) Lam Hoi Trading Co., Hong Kong, d) Shanghai Institute of Herbal Products, Shanghai, China, e) Shanghai Institute of Herbal Products, Shanghai, China

RECALLED BY:
Mayway Corp., Oakland, CA, by letter and telephone on 12/14/00, and by press release on 12/18/00. FDA-initiated recall *complete.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
Nationwide.

QUANTITY:
48 bags/lb; 15 bottles/3.5 oz.

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


Transgeniczna kukurydza w produktach kolejnych dwóch firm
(WPŁYW ŻYWNOŚCI TRANSGENICZNEJ
NA ŚRODOWISKO I ZDROWIE CZŁOWIEKA)

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April 11, 2001
FDA First Notice: 2 More Products Affected by Starlink Corn Recall

Washington, DC (SafetyAlerts) - The Food and Drug Administration (FDA) said today that two firms are recalling products that 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.

PRODUCT
Carroll Shelby’s Original Texas Brand Chili Kit, sales Units are 4 ounce kits (bags) packaged in 12 count, 60 count, 96 count or 120 count per box.

Recall #F-348-1.

CODE:
UPC codes with the following code dates:
12-count, UPC: 7239610000 Date Codes: 2920, 2930, 2940, 2970, 2980, 3040, 3050, 3070, 3080, 3140, 3150, 3190, 3200, 3210, 3220, 3250, 3270, 3320, 3330, 3340, 3350.

60-count, UPC: 7239670250 Date Codes: 2990, 3000.

96-count, UPC: 7239670230 Date Codes: 3060, 3110, 3120, 3130, 3180, 3190, 3260, 3270.

120-count, UPC: 7239670240 Date Codes: 3000, 3040, 3130, 3140.

MANUFACTURER:
Reily Foods Company, New Orleans, LA.

RECALLED BY:
Manufacturer, by letter on March 29, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
723,192 UNITS.

PRODUCT
Cheese enchiladas.

Recall #F-318-1.

CODE:
# 2103752, SYSCO Cheese Enchilada 1.625 oz./90 CT.

MANUFACTURER:
Fernando’s Food Corporation, Compton, CA.

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

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
California.

QUANTITY:
1,415 cases.

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


Niedostatecznie silnie działająca witamina C 
w kroplach multiwitaminowych z fluorem 
firmy Morton Grove Pharmaceuticals, Inc.

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

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April 12, 2001
MGP Multi-Vita Drops with Fluoride Recalled

Morton Grove, IL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Morton Grove Pharmaceuticals, Inc. has recalled certain MGP Multi-Vita Drops with Fluoride because of subpotency prior to expiration date; vitamin C (ascorbic acid.)

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

PRODUCT
a) MGP Multi-Vita Drops with Fluoride 0.25 mg., product code 8659, NDC 60432-659-50. Recalled #-158-1.

b) MGP Multi-Vita Drops with Fluoride 0.5 mg., product code 8496, NDC 60432-496-50. Recall #D-159-1.

CODES:
Product Code 8659, lots 22647A, 22431A, 22657A, 22534A, 22534C, 22534E, 22884-A, 22998A, 23077A, 23184A, 23232A, 23351A;

Product code 8496, lots 22308A, 22460A, 22602A, 22602C, 22769A, 23000A, 23000C, 23032A.

MANUFACTURER:
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL.

RECALLED BY:
Manufacturer, by letters dated 3/14/01. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
434378 – 0.25 mg. Fluoride bottles, 53323 – 0.5 mg. Fluoride bottles.

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


Nieprawidłowo podana data przedłużonej ważności na opakowaniu paracetamolu firmy Leiner Health Products, Inc.

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

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April 12, 2001
Leiner Health Products Inc. Recalls Acetaminophen Caplets

Carson, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Leiner Health Products, Inc. has recalled certain Acetaminophen Caplets because the labeling incorrectly declared an extended expiration date.

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

PRODUCT
OTC) Acetaminophen Caplets, Extra Strength, 500 mg, 24, 50,100, 120, 175, and 500 count.

Recall #D-152-1.

CODES:
Lot Number 1281 (Bulk Lot Numbers W9071027R, W9071028R, W9081167R, W9081168R, W9091370R, W9101447R, W0020276R)

Lot Numbers: 0010027, 0019523, 0044473, 0044390, 0044393, 0044641, 0044642, 0044643, 0044644, 0054814, 0055201, 0055202, 0055203, 0055204, 0055959, 0055960, 0067254, 0067255, 9082276, 9082277, 9082278, 9082280, 9082281, 9082282, 9082284, 9082285, 9082320, 9082321, 9082322, 9082323, 9093579, 9093579, 9094484, 9094485, 9094486, 9094487, 9094488, 9094490, 9094491, 9094492, 9094493, 9094494, 9094582, 9094583, 9094586, 9094588, 9094591, 9094592, 9094593, 9094705, 9105451, 9105857, 9106368, 9106369, 9106370, 9106371, 9106372, 9106375, 9106380, 9106385, 9106388, 9106391, 9106395, 9116914, 9117201, 9117217, 9117218, 9117223, 9117225, 9117227, 9117228, 9117230, 9117365, 9128851.

MANUFACTURER:
Leiner Health Products, Inc., Wilson, NC .

RECALLED BY:
Leiner Health Products, Inc., Carson, CA, by letter on January 15, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
AR, CT, FL, IN, MA, MN, NJ, NY, NC, OH, PA, and TN.

QUANTITY:
376,801 units were packaged and 362,953 units were distributed.

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


Koncentrat leku przeciwnowotworowego docetaxel 
w ampułkach oznaczonych jako rozpuszczalnik, 
lek Taxotere firmy Aventis Pharmaceuticals, Inc.

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

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April 12, 2001
Aventis Pharmaceuticals, Inc. Recalls Taxotere for Injection Concentrate

Kansas City, MO (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Aventis Pharmaceuticals, Inc. has recalled certain Taxotere (docetaxel) for Injection Concentrate because both the active ingredient vial and the diluent vial are labeled as diluents.

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

PRODUCT
Taxotere (docetaxel) for Injection Concentrate 20-mg., 20-mg. docetaxel in 0.5 ml polysorbate 80, 10 mg/ml after the initial dilution, RX, for IV infusion only, indicated for the treatment of breast cancer and non-small cell lung cancer, NDC #0075-8001-20, NDA #20-449.

The product consists of two vials. One vial contains the Taxotere and has a green flip-top cap, and the other vial contains Diluent for Taxotere 20 mg., containing 13% (w/w) ethanol in water for injection, and has a clear flip-top cap. The two vials are packaged together in a labeled tray. The tray is contained within a labeled box.

Recall #D-165-1.

CODES:
Lot #OP273 (Taxotere), OT446 (Diluent), Exp. 4/2002;
Lot #OP273 (Taxotere), OT449 (Diluent), Exp. 4/2002.

MANUFACTURER:
Aventis Pharma, Ltd., England, UK.

RECALLED BY:
Aventis Pharmaceuticals, Inc., Kansas City, MO, via telephone on 3/23/01 and by fax on 3/27/01. Firm-initiated recall ongoing.

DISTRIBUTION:
AL, CA, FL, IL, KY, MA, MI, MN, NC, NJ, OH, OR, SC, and TN.

QUANTITY:
28,774/2-vial units

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


Listeria monocytogenes w 6583 tonach produktów mięsnych 
firmy Bar-S Foods Co.

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

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April 13, 2001
14.5 Million lbs. Luncheon Meats, Hams, Sausages, Hot Dogs, Corn Dogs Recalled

Clinton, OK (SafetyAlerts) - Bar-S Foods Co. is voluntarily recalling approximately 14.5 million pounds of ready-to-eat meat and poultry products produced at its Clinton, Okla., establishment because the product may   be contaminated with Listeria monocytogenes.

Products being recalled include luncheon meats, whole hams, sausages, hot dogs, corn dogs, and various others, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

All products produced at the Clinton facility, with the exception of cook-in-bag products, are being recalled. The products bear code "EST 471" or "EST P-471" inside the USDA seal of inspection. Products were produced prior to March 30, 2001 and packages are marked "USE BY JUN 07 01" or earlier.

Jumbo hot dogs, sliced bacon, skinless smoked sausage are NOT involved in the recall.

No other Bar-S products are affected by this recall.

The products being recalled include meat and poultry products with the following brand names:

"Bar-S"
"Bar-S Extra Lean"
"Coronado"
"Chuck Wagon"
"E-Z Carve"
"Thrifty"

Also included are all "Bar-S" 1 lb. and 3 lb. packages of corn dogs with the establishment number "P-213" or "P-1843" on the package.

A complete list of recalled products is available here.

The products were distributed to retail establishments, delis, and institutions nationwide and shipped to Japan, Korea, Mexico, Puerto Rico, and the South Pacific.

"Because of the potential for foodborne illness, we urge consumers to check their refrigerators and freezers 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 they patronize if they purchased products that are subject to the recall."

The problem was discovered through FSIS microbiological testing. The Clinton plant has been voluntarily closed since March 29, 2001.

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.

FSIS has received no reports of illness associated with consumption of this product. Anyone concerned about an illness should contact a physician.

Consumers with questions about the recall may contact Leslie Pellillo, director of marketing, Bar-S Foods Co., at (602) 285-5293. Media with questions may contact Tom Weinman, vice president administration, Bar-S Foods Co., at (602) 264-7272.

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.


Niepoddane dostatecznej obróbce cieplnej i podejrzane o obecność Clostridium botulinum produkty kanadyjskiej firmy Primo Foods Company

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

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April 13, 2001
Primo Hearty Soups Recalls Two Ready-To-Serve Soups

Toronto (SafetyAlerts) - Primo Foods Company is warning the public not to consume the varieties of PRIMO Hearty Soups identified in the table below. These products may have been under-processed and there is a risk for the presence of bacteria that may be harmful, including the Clostridium botulinum bacteria.

The Company has received several reports of gastro-intestinal illnesses. No reports of C. botulinum have been received.

The products have been distributed nationally in Canada and with very limited distribution in the United States. The company stated they believe there were fewer than 3,500 cases distributed to the U.S. and distribution was primarily limited to eastern states, however could not provide a list of distribution points in the U.S.  No other Primo Foods products are affected by this recall.

Botulism is a life-threatening illness and initial symptoms are generally nausea and vomiting followed by blurred/double vision, difficulty in speaking, swallowing, general fatigue, lack of muscle coordination and respiratory impairment. Food contaminated with C. botulinum may not look or smell spoiled. The products should not be consumed by humans or animals.
 

     

    Product Description UPC Code
    PRIMO Hearty Soups Clam Chowder 
    ready-to-serve soup
    525 ml
    Canada Only
    0 5590000568 6
    PRIMO Hearty Soups Cream of Mushroom 
    with Portobello Mushrooms ready-to-serve soup
    540 ml
    Canada Only
    0 5590000593 8
    PRIMO Hearty Soups Clam Chowder 
    ready-to-serve soup
    539 g
    US Only
    0 5590030568 7
    PRIMO Hearty Soups Cream of Mushroom 
    with Portobello Mushrooms ready-to-serve soup
    539 g
    US Only
    0 5590030593 9


Primo Foods Company (Toronto, ON) is voluntarily recalling the affected products. Consumers should dispose of them immediately but should retain the labels for reimbursement by Primo Foods. Consumers can contact the Consumer Response Centre at 1 (877) 554-3577, from 9:00 am to 5:00 pm (DST). Consumers can forward the original label directly to Primo Foods Company at 2150 Lakeshore Blvd. West, Toronto, Ontario, M8V 1A3.

The Canadian Food Inspection Agency is monitoring the effectiveness of this recall.


Zgon dziecka i pożary z powodu chińskich zapalniczek
nieskuteczne zabezpieczonych przed użyciem przez dzieci

(bezpieczeństwo produktów w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
OGÓLNEGO BEZPIECZEŃSTWA PRODUKTÓW)

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April 17, 2001
Childs Death Prompts Recall of Disposable Lighters

Lighter recallHacienda Heights, CA (SafetyAlerts) - Gladstrong Investments USA has announced a voluntary recall affecting about 13 million disposable lighters. The lighters' child-resistant mechanisms are frequently ineffective. Young children are able to operate the lighters, posing a fire hazard.

CPSC and Gladstrong Investments have received a report of a 4- year-old girl who died after starting a fire with a Gladstrong Investments lighter and then hid in a closet. The fire caused an estimated $72,000 in damages. In another incident, two brothers, a 4- year-old and a 6-year-old, reportedly ignited clothing and paper inside a car while playing with one of these lighters causing about $1,500 in damages. They were not injured.

The recalled lighters have their brand name, "BODA-BING," "GIL," "HAPPY," or "WAX" stamped on both sides of their metal tops. The UPC bar code on the lighters' labels is "0-80692-99930-1," "0-295114-0" or starts with "7-55998." Writing on these lighters includes "MADE IN CHINA." The lighters were sold in various colors.

Convenience, drug and discount stores nationwide sold these lighters from January 1998 through February 2001 for about $1.

Consumers should stop using these lighters immediately and return them to the store where purchased for a refund. For more information, call Gladstrong at (877) 666-0664 between 9 a.m. and 5 p.m. PT Monday through Friday.

These lighters were discovered by CPSC surveillance and from reports from the Franklin, N.H. and Kenosha, Wis. fire departments.


Żrąca substancja chemiczna w kosmetyku oznaczonym
jako zmywacz do powiek firmy Markwins International

(jakość i skład kosmetyków w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE KOSMETYKÓW)

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Twoje prawo 
do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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April 18, 2001
FDA First Notice: Markwins International Recalls Beauty Briefcases

City of Industry, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Markwins International has recalled certain Beauty Briefcases because they contain bottles labeled as eye makeup remover that actually contain cuticle remover.

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

PRODUCT
Beauty Briefcase;

Recall #F-350-1.

CODE:
SKU # 50192.

MANUFACTURER:
Markwins International, City of Industry, CA.

RECALLED BY:
Manufacturer, by press release and newspaper ad on January 11, 2001. Firm-initiated recall *complete.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
Florida.

QUANTITY:
316 units.

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


Poparzenie dziecka z powodu łatwopalnego kostiumu dziecięcego 
firmy Disney

(bezpieczeństwo produktów w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE
OGÓLNEGO BEZPIECZEŃSTWA PRODUKTÓW)

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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April 19, 2001
Disney Store Recalls Children's Costumes

Disney store recalls childs costumeGlendale, CA (SafetyAlerts) - The Disney Store, of Glendale Calif., said today it is recalling about 54,000 Princess Ariel (The Little Mermaid) costumes. Fabric used in these costumes can ignite readily and presents a serious risk of burn injuries in violation of the Federal Flammable Fabrics Act, according to the U.S. Consumer Product Safety Commission (CPSC).

CPSC and Disney are aware of two reports of costumes igniting, resulting in one burn injury to a 4-year-old girl.

The Princess Ariel costume has a green skirt with two layers of netting on top and a sequined purple metallic bodice with a picture of Ariel. The costumes were sold in youth sizes 2-4, 4-6X and 8-10. The neckline labels read "The Disney Store."

The Disney Store sold the costumes for Halloween from July 2000 through October 2000. The Disney Store catalog and DisneyStore.com sold the costumes from July 2000 through January 2001. The costumes sold for about $29.

Consumers should stop wearing these costumes immediately, and return them to any Disney Store or to the Disney Store catalog for a refund and a $10 gift certificate. For more information, call Disney at (800) 328-5902 between 8 a.m. and 5 p.m. CT Monday through Friday, or e-mail the company at disneystore.costume@disneyonline.com.

The recall does not include Princess Ariel costumes sold before July 2000. The earlier Ariel costume was a mermaid fin-like costume with a knee-length, sequined skirt.


Pożary z powodu wad wewnętrznej instalacji elektrycznej aparatów suszarniczych firm Goldstar, General Electric i Sears Kenmore

(bezpieczeństwo produktów w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
OGÓLNEGO BEZPIECZEŃSTWA PRODUKTÓW)

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April 19, 2001
LG Electronics Inc. Recalls Certain Goldstar, General Electric, and Sears Kenmore Dehumidifiers

De-humidifiers recalledSeoul, South Korea (SafetyAlerts) - LG Electronics Inc. said today it is recalling about 100,000 Goldstar, General Electric, and Sears Kenmore portable dehumidifiers. These dehumidifiers have an internal electrical connection that can overheat, presenting a potential fire hazard to consumers, according to the U.S. Consumer Product Safety Commission (CPSC).

LG Electronics has received seven reports of dehumidifiers overheating, including four reports of fire within the units, with smoke damage to surrounding objects. No injuries have been reported.

The recalled dehumidifiers are white, with a red auto shut off button, and regulators for fan speed and humidity control. The dehumidifiers were manufactured between November 1998 and May 1999, and have the following brand names and model numbers: Goldstar DH2510, DH4010 and DH5010; General Electric AHG25LAG1, AHG40LAG1 and AHG50LAG1; and Sears Kenmore 580.59600 (60-pint model only). The brand name is located to the left of the control unit. The model number is located behind the condensate bucket, on a sticker on the left hand side.

Mass merchandise and department stores nationwide sold the dehumidifiers from January 1999 through December 1999 for between $100 and $200.

Consumers should stop using the dehumidifiers immediately and call LG Electronics toll-free (800) 651-1602 anytime for a free repair. Consumers also can log on the company's website at www.easyrecalldehumidifier.com.


Zatajona wieprzowina i mięso indyka 
w produktach firmy Ball Park Beef Franks

(POLSKIE PRZEPISY SANITARNE 
DOTYCZĄCE ARTYKUŁÓW SPOŻYWCZYCH)

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April 20, 2001
Ball Park Recalls Hot Dogs in Seven States

Southfield, MI (SafetyAlerts) - Ball Park Brands announced today that it is voluntarily recalling a specific lot of Ball Park Beef Franks across seven states because the packages are improperly labeled. While the package label indicates that beef is the only meat ingredient in these hot dogs, the franks are actually made with beef, pork and turkey.

The 1-pound packages of Ball Park Beef Franks being recalled have the establishment code EST 780 and a "use by" date of JUN 07 F34. The establishment code and "use by" date can be found on either the left or right edge on the front of the package. These hot dogs were distributed in the following seven states: Florida, Indiana, Michigan, Ohio, Oregon, Tennessee and Washington. A total of 18,504 pounds are being recalled. No other establishment codes and varieties are affected.

Product Description: Ball Park Beef Franks, 8 franks per 1-lb. package
Establishment code date: EST 780
"Use by" date: JUN 07 F34
Bar code: 545863

Consumers who have Ball Park Beef Franks with the establishment code of EST 780 and a "use by" date of JUN 07 F34 can return the product to the place of purchase for a full refund. Consumers with questions may call the Ball Park consumer line toll-free at 1-888-317-5867 or log on to the companies Web site at www.ballparkfranks.com.


Cząstki metalu w methocarbamolu chińskiej produkcji

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

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April 24, 2001
The Aceto Corporation Recalls Methocarbamol

Lake Success, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that The Aceto Corporation has recalled 140 lots of Methocarbamol because metal particles were found in the bulk active drug substance.

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

PRODUCT
(Rx) Methocarbamol,USP, bulk active pharmaceutical ingredient, 25 kilo drums.

Recall #D-171-1.

CODE:
Lot Nos. 79081-79188 and 89001-89032 (140 lots).

MANUFACTURER:
Tianjin Xin Xin Pharmaceutical Corp., Tianjin, China.

RECALLED BY:
The Aceto Corporation, Lake Success, New York, by letter on 4/17/98 and 6/25/98. Firm-initiated recall *complete.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
New York, Ohio, and Colorado.

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


Zagrażające trwałym uszkodzeniem układu nerwowego zatrucie dzieci ołowiem obecnym w  wysokim stężeniu na zewnętrznej powierzchni opakowania meksykańskich lizaków

(Metale szkodliwe dla zdrowia w polskich produktach:
ZANIECZYSZCZENIA
SUBSTANCJAMI CHEMICZNYMI I PROMIENIOTWÓRCZYMI
ORAZ 
TOKSYNAMI LIMITOWANYMI W ŚRODKACH SPOŻYWCZYCH)

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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April 26, 2001
FDA Alerts Public to Possible Health Risk Associated with Certain Tamarind Candy Lollipops from Mexico

Washington, DC (SafetyAlerts) - FDA is warning consumers to avoid purchasing or consuming tamarind candy lollipops labeled Dulmex brand "Bolirindo" because of high levels of lead that may be associated with the product - especially its wrapper. People, especially children, who consume high levels of lead can suffer serious damage to their central nervous systems - sometimes leading to permanent neurological damage.

Routine lead level testing of children conducted by the California Department of Health Services revealed at least three cases where 2 year old children may have suffered elevated lead levels as a result of contact with this candy. These findings lead the California Department of Health Services and FDA to analyze this product for lead contamination. Although sampling and analyses of this product continues, preliminary findings indicate that at least the lollipop wrapper's exterior may have exceedingly high concentrations of lead (21,000 parts per million).
In light of these preliminary findings and reported injuries FDA is urging consumers not to consume these lollipops and to keep them out of childrens' hands. Eating the lollipops may expose them to dangerously high levels of lead, especially if the candy becomes damp or if the wrapper is chewed or eaten. Anyone who suspects they or their child may have consumed these lollipops may want to consult their doctor about having their lead level checked.

The product is a soft, dark brown, tamarind fruit candy lollipop on a white or orange stick. It is wrapped in an orange-red wrapper with "BOLIRINDO" in white lettering and picture of a brown tamarind fruit. The product is known to be distributed in California, but may also be present in other parts of the country, particularly in Southwestern states.


Salmonella sp. w pepsynie wchodzącej w skład suplementu dietetycznego
firmy Solgar Vitamin and Herb Company

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

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April 30, 2001
Solgar Vitamin And Herb Company Recalls Solgar's Digestive Aid 100's Dietary Supplements

Leonia, NJ (SafetyAlerts) - Solgar Vitamin and Herb Company is recalling 754 bottles of Solgar's Digestive Aid 100's dietary supplements, because they have the potential to be contaminated with Salmonella.

Bottles of Solgar's Digestive Aid 100's were distributed from March 30, 2001, to April 20, 2001, to retail stores nationwide and in some foreign countries, including the United Kingdom, France and Israel.

Samonella is an organism which 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 fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The product comes in brown bottles with yellow labels that have an orange stripe on the bottom. The bottles being recalled are marked with lot numbers 31993 or 30957 that are printed above the expiration date on the bottle neck. The label reads in part, "Solgar Digestive Aid - Dietary Supplement - 100 Tablets - Sugar and Starch free."

No illnesses from this product have been reported to date.

The recall was the result of a routine sampling program by American Laboratories Inc., of Omaha, Nebraska, which detected Salmonella in the raw material, pepsin, that was used in Solgar's dietary supplement. FDA's investigation of the situation continues.

Consumers who purchased this product are urged to not consume it and should instead destroy it or return it to the place of purchase for a full refund. Consumers with questions may contact the company at 201/944-2311.


Zatajona farba w produktach firmy Crystal Soda Water Company Inc.

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

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May 2, 2001
FDA First Notice: Crystal Soda Water Company Inc. Recalls Orange Soda

Scranton, PA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Crystal Soda Water Company, Inc. has recalled certain Orange Soda because the recalled product contains undeclared FD&C Yellow No.6.

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

PRODUCT
Orange Soda.

Recall #F-309-1.

CODE:
Two liter sizes lots: 01901,03601,03901,05301,and 05401.12 fluid ounce size lots: 05101 and 03201.

MANUFACTURER:
Crystal Soda Water Company, Inc., Scranton, PA

RECALLED BY:
Manufacturer, by letter dated 3/21/01 delivered by drivers. The manufacturer also issued stick on labels stating that the product contains Yellow #6 for the drivers to affix. Firm initiated recall *complete.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
PA.

QUANTITY:
680 cases (24/12 oz cans per case) and 1868 cases (8/2 liter bottles per case).

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


Zatajona mąka pszenna w barszczu i kapuśniaku marki Dudek

(NIEPOŻĄDANE REAKCJE NA PRODUKTY SPOŻYWCZE)

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May 2, 2001
Dudek Brand Barszcz and Kapusniak Soups

Hamtramck, MI (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Dudek Foods, Inc. has recalled certain Dudek brand Barszcz and Kapusniak soups because the recalled product contains undeclared wheat flour.

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

PRODUCT
a) Dudek brand Barszcz (Beet Soup) in 32 fl. oz. (1 QT) glass jars. Recall #F-366-1

b) Dudek brand Kapusniak (Cabbage Soup) in 32 fl. oz. (1 QT) glass jars. Recall #F-367-1

CODE:
a) Beet Soup, Lot with expiration date “5 2301”.
b) Cabbage Soup, Lot with expiration date “115 01”.

MANUFACTURER:
Dudek Foods, Inc., Hamtramck, MI.

RECALLED BY:
Manufacturer, by telephone and visit, beginning on March 3, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
Michigan.

QUANTITY:
Approximately 182 jars of Beet Soup and 210 jars of Cabbage Soup.

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


Zagrażające pożarem 284 000 baterii do przenośnych komputerów 
firmy Dell

(bezpieczeństwo produktów w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
OGÓLNEGO BEZPIECZEŃSTWA PRODUKTÓW)

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May 3, 2001
Dell Computer Recalls 284,000 Notebook Batteries

Dell battery recallAustin, TX (SafetyAlerts) - Dell Computer Corp. is voluntarily recalling about 284,000 batteries used in notebook-style personal computers. These batteries can overcharge, causing them to become very hot, release smoke, and possibly catch fire.

Dell has received one report of a battery overcharging, resulting in minor property damage. No injuries have been reported.

The recalled batteries were sold in Dell Inspiron 5000 and 5000e notebook computers and sold separately for use in both of these systems. The words, "DELL," "MADE IN JAPAN," and "Inspiron 5000 Battery Module" are printed on the top of the batteries. An identification number is written on a colored sticker at the rear of the battery. Those batteries that have colored stickers containing either the number "99" or the series "00 51" or less, and the letter "P" in the first line, are being recalled.

Dell sold these batteries nationwide through catalogs and over the Internet from January 2000 through March 2001. The computers with these batteries were sold for between $2,100 and $3,100, and individual batteries were sold for between $100 and $130.

Consumers should stop using these batteries immediately and call Dell toll-free at (877) 237-3355 or go to Dell's website at www.dell.com to order a free replacement battery. Consumers also can write to the company at Dell Computer Corporation, RR2E, MSC #8222, One Dell Way, Round Rock, TX 78682.

In October 2000, Dell recalled certain Dell Notebook computer batteries for the Inspiron 3700 and 3800 systems.

Notice of this product warning was sent via email to SafetyAlerts subscribers May 3, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.


Witamina A w zagrażającej zdrowiu dawce 
w produktach firmy Metabolife International

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

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 8, 2001
Metabolife Recalls Its Metabolife Diet & Energy Bars

San Diego, CA (SafetyAlerts) - Metabolife International has issued a voluntary recall of all of its Metabolife Diet & Energy Bars manufactured through May 4, 2001, because the products contain a significantly higher-than-labeled level of vitamin A (approximately 32,500 IU per bar).  The problem was reportedly due to an error by the contract manufacturer, MLO Products, Inc.

Excessive amounts of vitamin A can cause severe health problems. Specifically, large amounts of vitamin A (more than 25,000 International Units or IU) can cause severe liver damage (including cirrhosis), bone and cartilage abnormalities, increased pressure in the brain, and birth defects in infants whose mothers consumed vitamin A during pregnancy. Those especially vulnerable to vitamin A toxicity are children, including those breast fed by mothers consuming excessive amounts of vitamin A, pregnant women, and those with liver disease caused by alcohol, viral hepatitis, and severe protein-calorie deficiency, according to a statement by the company

The Metabolife Diet & Energy Bars were distributed from December 25, 2000, to May 4, 2001, to retail stores nationwide. The two-ounce dietary supplement bars have a red label that reads, in part, "Metabolife Diet & Energy Bar." These products come in Outrageous Oatmeal Raisin, Perfectly Peanut, Downright Chocolate and Lemony Lemon flavors. All lots produced to date are subject to this recall.

No illnesses from this product have been reported to date. No other Metabolife products are affected by this recall.

"Metabolife discovered the excessive vitamin A amounts during Metabolife's own quality assurance sampling audit, which was confirmed by independent testing by the manufacturer," stated Metabolife's CEO, David Brown. "We are voluntarily recalling this 4-month-old product as a responsible company."

Consumers who purchased a Metabolife Diet and Energy Bar should return it to the place of purchase for full refund, or destroy the product. Consumers with questions may call (800) 540-7099. Again, no other Metabolife products are affected by this recall.


Potencjalnie śmiercionośna Escherichia coli O157H7 
w mielonym mięsie wołowym

(Bakterie w polskich produktach:
ZANIECZYSZCZENIA MIKROBIOLOGICZNE
LIMITOWANE W ŚRODKACH SPOŻYWCZYCH)
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Twoje prawo 
do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 9, 2001
Emmpak Foods Inc. Recalls 254,000 Lbs of Frozen Hamburger Patties

Butler, WI (SafetyAlerts) - Emmpak Foods, Inc. is voluntarily recalling approximately 254,000 pounds of frozen hamburger patties that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

The products being recalled bear the establishment number "924A" inside the USDA seal of inspection. Products subject to recall are:

     
    "Hamburger Patties 100% Pure Beef" in ten pound cases, marked with a case code starting with "2940." This product was produced on Oct. 20, 2000.
    "Steak n’ Shake BEEF STEAKBURGER (CHOPPED AND FORMED)" in 16 pound cases, marked with a date code starting with "PACKED ON W 02-08-01." This product was produced on Feb. 8, 2001.
These products were distributed to retail and institutional establishments in Alabama, Arkansas, Florida, Kentucky, Illinois, Indiana, Mississippi, New Mexico, New York, Pennsylvania, South Carolina, and Wisconsin.

The problem was discovered when officials in Georgia contacted FSIS about a suspected illness associated with this product. FSIS’s samples of the product tested positive for E. coli O157:H7. A link between the illness and the product has not been confirmed.

"Because of the potential hazard of foodborne illness from consumption of meat products contaminated with harmful bacteria such as E. coli O157:H7, I urge consumers who have purchased the suspect product not to eat it and return it to the place of purchase," said Thomas 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 may also wish to ask restaurants and institutions they patronize where their ground beef was produced."

E. coli O157: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 susceptible to foodborne illness.

Consumers with questions about the recall may contact Robert Segel, Emmpak’s vice president of public affairs, at (414) 645-6500. Media with questions may contact Ron Irwin, Emmpak’s company spokesperson, at (414) 390-5500.


Lek stosowany w grzybicach
- Sporanox® (itraconazole)  firmy Janssen Pharmaceutical Products
- powoduje niewydolność mięśnia sercowego i wątroby,
Amerykański Urząd ds. Żywnosci i Leków  zarejestrował 11 zgonów łączonych z tym lekiem.

Lek stosowany w grzybicach
Lamisil® (terbinafine hydrochloride)  firmy Novartis Pharmaceuticals
- powoduje niewydolność wątroby,
Amerykański Urząd ds. Żywnosci i Leków  zarejestrował 13 zgonów łączonych z tym lekiem.

Amerykański Urząd ds. Żywnosci i Leków wydał ostrzeżenia, producenci pisemnie powiadamiają lekarzy.

W Polsce zarejestrowane są m. in. następujące preparaty:

  1. Orungal (Janssen)
  2. Sempera (Janssen)
  3. Sporanox (Janssen)
  4. Lamisil dla dorosłych i dla dzieci (Novartis)


(jakość i skład leków w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
ŚRODKÓW FARMACEUTYCZNYCH
I MATERIAŁÓW MEDYCZNYCH)
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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 9, 2001
FDA Issues Health Advisory Regarding the Safety of Sporanox® Products and Lamisil® Tablets
to Treat Fungal Nail Infections

The Food and Drug Administration (FDA) today issued a Public Health Advisory to announce significant safety-related updates to the labeling of Sporanox® (itraconazole) products and Lamisil® (terbinafine hydrochloride) tablets. Sporanox® and Lamisil® are used to treat nail (onychomycosis), skin and other systemic fungal infections. The following may be used to answer questions.

The purpose of today's FDA Public Health Advisory is to alert healthcare professionals to serious risks associated with the use of Sporanox® and Lamisil®.

FDA believes there is a small but real risk of developing congestive heart failure (CHF) associated with the use of Sporanox®. Both Sporanox® and Lamisil® have been associated with serious liver problems resulting in liver failure and death. However, there is insufficient data to allow FDA to make any kind of statement about the comparative safety of Sporanox® and Lamisil®.

Results of recent studies of Sporanox® revealed a potential for the drug to weaken the force of the heart muscle's contractions. This so-called "negative inotropic effect" was observed when intravenous Sporanox® was injected into anesthetized dogs and healthy human volunteers. In these studies, the adverse effect on the heart muscle resolved once the drug was stopped.

Since becoming aware of the study findings, FDA analyzed US and international post-marketing adverse event reports involving Sporanox that were received between its approval in September 1992 and April 2001.

During this period, FDA received 94 cases in which patients receiving Sporanox® developed CHF. In 58 of the 94 cases, FDA believes Sporanox® contributed to or may have been the cause of CHF. In 26 of these 58 cases, Sporanox® was being administered to treat fungal nail infections. Of these 58 patients, 28 were hospitalized. Death was reported in 13 cases. However, the causal relationship between the 13 deaths and Sporanox® is very unclear because of confounding factors. For example, 10 of the 13 patients who died had serious underlying conditions.

In response to the study findings and the analysis of the post-marketing adverse event reports, FDA has added additional information to the current "black box" warning in the Sporanox® labeling. The warning now states that Sporanox® should not be administered for the treatment of fungal nail infections in patients with evidence of cardiac dysfunction, such as CHF, or a history of CHF. The Sporanox® "black box" warning also includes important information about heart-related adverse events caused by drug interactions.

If signs and symptoms of CHF occur during treatment of fungal nail infections, the revised labeling recommends that Sporanox® should be discontinued. If signs and symptoms of CHF occur during treatment for more serious fungal infections involving other parts of the body, the revised labeling recommends that continued use of Sporanox® should be reassessed by the physician.

The advisory also alerts healthcare professionalsto rare cases of serious liver problems including liver failure, transplantation and death associated with the useof Sporanox® products and Lamisil® tablets. While adverse liver effects were already included in the labeling for both products, FDA decided to include this information in the advisory because some cases involved patients who had neither pre-existing liver disease nor a serious underlying medical condition.

FDA's concerns do not apply to the topically applied versions of Lamisil® such as cream and solution.

As of April 2001, FDA has received and reviewed 16 possible Lamisil®-associated cases of liver failure, including 11 deaths and two liver transplantations.

As of March 2001, FDA has received and reviewed 24 cases of liver failure possibly associated with Sporanox®, including 11 deaths. Approximately half of the liver failure cases received Sporanox® for fungal nail infections or other dermatological infections.

Given the possible serious risks associated with Sporanox® products and Lamisil® tablets, the new labeling for both products now recommends that healthcare professionals should obtain nail specimens for laboratory testing prior to prescribing the medications for fungal nail infections, to confirm the diagnosis.

In conjunction with FDA's advisory, the manufacturer of Sporanox® (Janssen Pharmaceutica Products, L.P. of Titusville, NJ and Ortho Biotech Products, L.P. of Raritan, NJ) and Lamisil® (Novartis Pharmaceuticals of East Hanover, NJ) are notifying healthcare professionals of the labeling changes by issuing "Dear Healthcare Professional" letters.

FDA encourages healthcare professionals and patients to report adverse events associated with the use of Sporanox® and Lamisil® to FDA's MEDWATCH Program. Reports may be submitted to MEDWATCH by phone at 1-800-FDA-1088, by fax at 1-800-FDA-1078, by mail at MEDWATCH, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MEDWATCH web site at www.fda.gov/medwatch.
 

The full text of the FDA Public Health Advisory is available at FDA's MedWatch web site, http://www.fda.gov/cder/drug/advisory/sporanox-lamisil/advisory.htm.
 
 

FDA PUBLIC HEALTH ADVISORY
THE SAFETY OF SPORANOX® CAPSULES AND LAMISIL® TABLETS
FOR THE TREATMENT OF ONYCHOMYCOSIS

The Food and Drug Administration (FDA) is issuing a public health advisory concerning Sporanox® (itraconazole) Capsules and Lamisil® (terbinafine hydrochloride) Tablets for the treatment of onychomycosis. It is important for physicians to be aware of the association of congestive heart failure and hepatic adverse events with the administration of these therapies. Prior to prescribing systemic antifungal drug therapy for the treatment of onychomycosis, healthcare professionals should consider this new safety information.

Sporanox® Capsules and Lamisil® Tablets, synthetic antifungal agents, are approved in the United States for the treatment of onychomycosis [Sporanox® Capsules, Oral Solution, and Injection are also approved for the treatment of serious systemic fungal infections (e.g., esophageal candidiasis, aspergillosis, blastomycosis, and histoplasmosis).]

CARDIAC RISKS

FDA believes that there is a small but real risk of developing congestive heart failure associated with Sporanox® therapy. Recent studies conducted in dogs and healthy human volunteers revealed negative inotropic effects with intravenous (IV) itraconazole. In these studies, once the drug was stopped the negative inotropic effects resolved. The mechanism for these cardiac effects has not been determined.

Since becoming aware of these findings, FDA reviewed spontaneous post-marketing reports received between September 1992 and April 2001 for congestive heart failure (CHF) in association with itraconazole use. During this period, FDA received 94 U.S. and international spontaneous reports of CHF in which itraconazole was listed as a suspect drug. In 58 of the 94 cases, FDA believes itraconazole contributed to or may have been the cause of CHF. In 26 of the 58 cases, itraconazole was being administered for the treatment of onychomycosis. Of these 58 cases, 28 were hospitalized. Death was reported in 13 cases. However, the causal relationship between the 13 deaths and itraconazole is unclear because of confounding factors, including 10 of the 13 patients who had serious underlying conditions.

Because of the low but possible risk of cardiac toxicity, Sporanox® should NOT be administered for the treatment of onychomycosis in patients with ventricular dysfunction such as CHF or a history of CHF. If signs or symptoms of CHF occur during treatment for onychomycosis, Sporanox® should be discontinued.

If signs or symptoms of CHF occur during treatment for more serious systemic fungal infections, continued Sporanox® use should be reassessed as to the appropriate risk benefit analysis in relationship to any other therapeutic options.

HEPATIC RISKS

Both Sporanox® and Lamisil® have been associated with serious hepatic toxicity, including liver failure and death, including some cases involving patients who had neither pre-existing liver disease nor a serious underlying medical condition.

As of April 2001, the FDA is aware of 16 cases of liver failure in association with Lamisil® Tablet use (including 11 deaths and two liver transplantations). These patients received Lamisil® Tablets for the treatment of various dermatologic conditions, including onychomycosis.

FDA's concerns about hepatic risks associated with the use of Lamisil® do not apply to topically applied formulations of terbinafine, such as Lamisil® Solution and Lamisil® AT Cream.

As of March 2001, the FDA is aware of 24 cases of liver failure associated with Sporanox® use (including 11 deaths). These patients received Sporanox® for the treatment of either onychomycosis or systemic fungal infections.

Given the possible risks associated with both drugs, FDA wants healthcare providers to be aware of this new safety information for the two most commonly prescribed systemic onychomycosis drug therapies. Because of these risks, the new labeling for both Sporanox® and Lamisil® recommends that healthcare providers obtain nail specimens for laboratory testing prior to prescribing the medications for onychomycosis to confirm the diagnosis. However, there is insufficient data to allow FDA to make any kind of statement about the comparative safety of Sporanox® and Lamisil®.


Pleśnie w napojach firmy Coca-Cola

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

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Twoje prawo 
do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 10, 2001
FDA First Notice: Minute Maid Fruit Punch Recalled

Atlanta, GA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Coca-Cola USA Operations has recalled certain Minute Maid Fruit Punch because the product was contaminated with mold.

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

PRODUCT
Minute Maid Fruit Punch in 16-oz. PET Bottles.

Recall #F-381-1.

CODE:
NOV0501HFB.

MANUFACTURER:
The Minute Maid Company of Coca-Cola USA at Hi Country Foods, Selah, WA.

RECALLED BY:
Coca-Cola USA Operations, Atlanta, GA, by email on 2/15/01. Firm-initiated recall *completed.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
IL, IN, IA, MI, MN, MO, MT, NE, ND, OH, WA, WI & WY.

QUANTITY:
9,840 cases.

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


Sfermentowane napoje firmy Coca-Cola

(POLSKIE PRZEPISY SANITARNE 
DOTYCZĄCE ARTYKUŁÓW SPOŻYWCZYCH)

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 10, 2001
FDA First Notice: Minute Maid Orange Juice Recalled

Atlanta, GA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Coca-Cola USA Operations has recalled certain Minute Maid Orange Juice products because the product was fermented.

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

PRODUCT
a) Minute Maid 100% Orange Juice. Recall #F-382-1;
b) Minute Maid 100% Orange Juice plus Calcium. Recall #F-383-1.

CODE:

a) Minute Maid OJ - JUN1101CCB, JUN1101CCC,JUN1101CCD, JUN1101CCE, JUN1801CCB, JUN1801CCC, JUN1801CCD and JUN1801CCE;

b) Minute Maid OJ plus Calcium - JUN1101CCD and JUN1101CCE.

MANUFACTURER:
The Minute Maid Company of Coca-Cola at United Packers, Chattanooga, TN.

RECALLED BY:
Coca-cola USA Operations, Atlanta, GA., on February 1, 2001 by email. Firm-initiated recall *complete.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
Nationwide.

QUANTITY:
153,784 cases.

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


Pożary z powodu wady 60 000 faksów firmy Canon

(bezpieczeństwo produktów w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE
OGÓLNEGO BEZPIECZEŃSTWA PRODUKTÓW)

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 10, 2001
Canon U.S.A. Recalls 60,000 Fax Machines

Canon FAX Machine RecalledLake Success, NY (SafetyAlerts) - Canon U.S.A. Inc. is voluntarily recalling about 60,000 Faxphones. The Faxphones are combination plain-paper copiers and facsimile machines. A component failure can cause the Faxphone to catch on fire.

Canon U.S.A. received five reports of Faxphones catching on fire and causing damage to the machines. No injuries have been reported. The recall involves Canon Faxphones with model number B640. "FAXPHONE B640" is written on the front of the machines. The units being recalled have serial numbers UKK52923 to UKK55442, UKK60513 to UKK99999, and YKK02001 to YKK20000. The serial number is printed on a silver label located on the back of the machines.

Electronics, office products and computer stores nationwide sold these machines from October 1999 through May 2001 for between $130 and $200.

Consumers should stop using the Faxphones immediately, and contact Canon U.S.A. Inc. to get a free replacement Faxphone. For more information, consumers should call Canon at (888) 280-7858 between 8 a.m. and 12 a.m. ET Monday through Friday, and between noon and 8 p.m. ET Saturday, or visit Canon's web site at www.cusa.canon.com/consumer.


Zanieczyszczenie mikrobiologiczne prepratów Tyzine firmy Kenwood Therapeutics

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

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Twoje prawo 
do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 11, 2001
Tyzine Tetrahydrozoline HCI Nasal Spray and Pediatric Nasal Drops Recalled

Pawtucket, RI (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Kenwood Therapeutics has recalled Tyzine Tetrahydrozoline HCI Nasal Spray and Pediatric Nasal Drops because of high counts of microbiological contamination.

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

PRODUCT
Tetrahydrozine HCI Nasal Spray 0.1% and Pediatric Nasal Drops 0.05%. Brand name-Tyzine. Both 15 ml (1/2 Fl oz) units NDC numbers 0482-4770-15 and 0482-4760-15.

Recall #D-195-1; Recall#D-196-1.

CODE:
0.1% -- Lot 6234 exp.8/2002;
0.05% -- lot 6235 exp. 8/2004.

MANUFACTURER:
Denison Pharmaceuticals, Inc., Pawtucket, RI.

RECALLED BY:
Kenwood Therapeutics, by letter on March 24, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
Lot 6235--25,397 units; Lot 6234 -- 11,595 units.

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


Wada jakościowa antybiotyku Keftab (cephalexin) firmy Eli Lilly

W Polsce zarejestrowane są m. in. następujące preparaty:

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

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 11, 2001
Eli Lilly and CO. Recalls Keftab Tablets

Indianapolis, IN (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Eli Lilly and Co. has recalled Keftab tablets because of problems with dissolution properties.

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

PRODUCT
Keftab (Cephalexin Hydrochloride) 500mg. NDC 5147-9034-02, 6445-034-02, 64455-034-01 and 64455-034-10. Keftab tablets are sold in bottles of 100 and 60 count blisters.

Recall #D-191-1.

CODE:
Lot #         Expiration date
3AP73A      10/1/01
3AR48A      1/1/02
3AS36A      2/1/02
3AS37A      8/1/02
3AD93A      4/1/01
3AD94A      4/1/01
3AD96B      4/1/01
3AE63B      4/1/01
3AG03A      5/1/01
3AG38A      4/1/01
3AG40A      10/1/00
3AG73A      5/1/01
3AH64A      8/1/01
3AH65A      2/1/01
3AM54A     10/1/01
3AM55A     10/1/01
3AP74A     10/1/01
3AR46A     12/1/01
3AR47A     6/1/01
3AR49A     1/1/02
3AR50A     1/1/02
3AS34A     2/1/02
3AS35A     2/1/02
3AS36A     2/1/02
3AS37A     2/1/02
3AS38A     2/1/02
3AS39B     8/1/01
4AA77A     2/1/02
4AA78A     8/1/02
4AD08A     5/1/02
4AD09A     11/101
4AD10M     12/1/01
4AE21A     6/1/02
4AE22A     12/1/01
4AE23M     1/1/02
4AE24M     2/1/02
4AE25B     2/1/02
4AE26B     8/1/02
4AF21D     8/1/02
4AF22A     8/1/02
4AF23A     8/1/02
4AF24A     8/1/02
4AG82A     3/1/02
4AG83D     9/1/02
4AG84M     3/1/02
4AK36C     3/1/02
4AK37A     9/1/02
4AK38B     9/1/02
4AK39A     9/1/02
4AK40A     10/1/02
4AK41B     10/1/02
4AK42B     4/1/02
4AK44C     4/1/02
4AL40A     8/1/02
4AM60A     9/1/02
4AN34B     11/1/02
4AN35A     11/1/02

MANUFACTURER:
Lilly del Caribe, Carolina, PR.

RECALLED BY:
Eli Lilly and CO., Indianapolis, IN, by letters dated 3/27/0. Firm-initiated recall *complete.

*Completed recall: FDA states 'completed recall' indicates the company has removed all affected product from store shelves,  it does not necessarily mean this particular product lot, or codes, have been fully accounted for.

DISTRIBUTION:
Nationwide.

QUANTITY:
45,189,243 units.

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


Zatajone siarczyny w suszonych pomidorach firmy Kirsch

(dawki E 221 - E 228 w polskich produktach:
KONSERWANTY ŻYWNOŚCI I NAPOJÓW
NIEPOŻĄDANE REAKCJE NA PRODUKTY SPOŻYWCZE)

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May 14, 2001
Kirsch's Recalls Sun-Dried Tomatoes

Bronx, NY (SafetyAlerts) - Kirsch's sun dried Tomatoes is recalling 783 - 3 oz. net packages of sun-dried tomatoes because the product may contain undeclared sulfites.

No illnesses have been reported.

People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

The product was distributed in New York and New Jersey, and was sold in Shop-Rite supermarkets.

The product is packed 3 oz. net in a see through clamshell container, coded Nov. 1, 2001 25178.

Routine sampling of by the NYS Department of Agriculture Markets food inspectors turned up the problem. The recall was initiated after it was discovered that product containing Sulfur Dioxide was distributed in packaging that did not reveal the presence of Sulfur Dioxide. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes. Production of the product has been suspended until the company is certain that the problem has been corrected.

Consumers who have purchased the product may return it to the place of purchase for a full refund.


Zatajone siarczyny w suszonych morelach
nowojorskiej firmy Mon Chong Loong Trading Corp.

(dawki E 221 - E 228 w polskich produktach:
KONSERWANTY ŻYWNOŚCI I NAPOJÓW

NIEPOŻĄDANE REAKCJE NA PRODUKTY SPOŻYWCZE)

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May 14, 2001
New York Firm Recalls Dried Apricot

Maspeth, NY (SafetyAlerts) - Mon Chong Loong Trading Corp. is recalling 50 cases of dried Apricot because the product may contain undeclared sulfites.

No illnesses have been reported to date according to a company statement.

People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

The product is packed in 7 oz. plastic bags, is orange in color and "packed by Tim Heung Yuen Nut & Confectionery Ltd., Kwai Chung, N.T." is printed on the back of the product. The product was distributed in New York.

Consumers who have purchased the product are urged to return it to the place of purchase for a full refund. Consumers with questions can reach the company at 718-417-1668.


Niedomykające się drzwiczki kuchenek mikrofalowych firmy BSH Home Appliances Corp.

(bezpieczeństwo produktów w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE 
OGÓLNEGO BEZPIECZEŃSTWA PRODUKTÓW)

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May 17, 2001
BSH Home Appliances Corp. Recalls Thermal/Microwave Ovens

Thermal ovenLos Angeles, CA (SafetyAlerts) - BSH Home Appliances Corp. said today it is recalling about 2,300 Thermador® brand combination thermal/microwave ovens. The oven door may not lock properly when the oven is put into the "self clean" mode. While the oven is in "self clean" mode, intense heat is generated to clean the oven. If oxygen is introduced by opening the oven door during the "self clean" mode, combustible material left inside can ignite and pose a fire risk.

The oven has a steel frame around glass panels and comes in a black, white or stainless steel finish. It is sold as a single or double-stacked unit. The model numbers included in the recall are CM301UB, CM302UB, CM301UW, CM302UW, CM301US, and CM302US with serial numbers that begin with 2003 through 2010. The model and serial numbers are located on a data plate inside the grill located beneath the control panel that reads "Thermador" on the right hand side of the oven.

Appliance and specialty stores nationwide sold the ovens to homebuilders and contractors from about May 2000 through May 2001 for about $3,000 to $4,600.

INCIDENTS/INJURIES: None reported.

Consumers should stop using the "self clean" mode of the recalled ovens immediately and contact Thermador at (800) 735-4328 between 5 a.m. and 5 p.m. PT Monday through Friday to arrange for a free inspection and if needed, free repair. Media inquiries should be directed to Gary Ball at (714) 899-4166.


Niedozwolona farba C.I. Acid Blue #80 w mydłach firmy Steiner

(jakość i skład kosmetyków w Polsce:
POLSKIE PRZEPISY DOTYCZĄCE KOSMETYKÓW)

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 17, 2001
Steiner Company Inc. Recalls Anti-Microbial Hand Soap
and Fresh-N-Clean Hand Washing and Sanitizing Compound

Holland, OH (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Steiner Company Inc. has recalled certain ANTI-MICROBIAL HAND SOAP and FRESH-N-CLEAN Hand Washing and Sanitizing Compound because the products contain unapproved dyes.

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

PRODUCT
FRESH-N-CLEAN Hand Washing and Sanitizing Compound, packaged in one (1) gallon containers, 4 containers per case. The active ingredient is: Didecyldimethylammonium Chloride (trade name: BARDAC 2250).

Recall #D-203-1.

CODE:
Case codes: 050697, 090397, 082698, 0824991, and 1116991.

MANUFACTURER:
Steiner Company, Inc. Holland, OH.

RECALLED BY:
Manufacturer, on 4/10/2001, by faxed and letter. Firm-initiated recall ongoing.

DISTRIBUTION:
Ohio.

QUANTITY:
768 cases.

REASON:
The product contains C.I. Acid Blue #80; C.I. 61585 (trade name: Sandolin Milling Blue N-BLA Powder 150), which is an unapproved dye.

PRODUCT
ANTI-MICROBIAL HAND SOAP, packed in 800 ml bags (inside a box), for use in the ěBag-In-Boxî dispensers, 12 per case. This is an OTC drug product; the active ingredient is parachlorometaxylenol (PCMX).

Recall #D-199-1.

CODE:
C022161, C021371, C040371, C050571, C062672, C071971, C112271, C011381, C041381, C071781, C121581, C021691, C030391, C052591, C071391, C072991, C082691, C090891, C110391, C121591, C031401, C040501, C060101, C071001, C091401, and C110801.

MANUFACTURER:
Steiner Company, Inc. Holland, OH.

RECALLED BY:
Manufacturer, by facsimile on 4/2/2001. Firm-initiated recall ongoing.

DISTRIBUTION:
Illinois.

QUANTITY:
6,899 cases.

REASON:
The product contains C.I. Acid Yellow #36 (trade name: Metanil Yellow), which is an unapproved dye.

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


Zatajone farby w produktach Jadine Food Products Inc.

(dawki E 110 i E 129 w polskich produktach:
BARWNIKI ŻYWNOŚCI I NAPOJÓW)

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do bezpieczeństwa i odszkodowania za uszkodzenie ciała lub rozstrój zdrowia
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May 17, 2001
Jadine Food Products Inc. Recalls Duck Sauce

Ridgewood, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Jadine Food Products Inc. has recalled certain Duck Sauce because the product contained undeclared FD&C Yellow No. 6 and FD&C Red No. 40.

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

PRODUCT
Duck Sauce in single serve packets, 1 gallon jugs and 5 gallon pails.

Recall #F-411-1.

CODE:
No codes.

MANUFACTURER:
Jadine Food Products Inc., Ridgewood, NY.

RECALLED BY:
Manufacturer, by letter, dated 4/24/01. Firm-initiated recall ongoing.

DISTRIBUTION:
NY and NJ.

QUANTITY:
470 cases (500 packets per case) of the single-serve packets, 10 cases (4 - 1 gal jugs per case) of the 1 gallon jugs, and 316 - 5 gallon pails were distributed since 3/16/01.

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



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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
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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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