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Larry Davis for The New York Time
Harish Bharti, a lawyer in Seattle, has filed a lawsuit against McDonald's on behalf of Hindus and vegetarians. They charge that the company has misled customers about its use of beef in French fries.

As an observant Hindu, Brij Sharma considers cows sacred. He believes the gentle creatures are helpmates to human beings, and it would be as unthinkable for him to eat beef as it would for a cowboy in Montana to eat his own horse.

Not surprisingly, Mr. Sharma, an electrical engineer for Boeing in Seattle, says that for years he never set foot in a McDonald's restaurant. But in 1990, when the fast-food chain announced with great fanfare that it was switching from beef fat to "100 percent vegetable oil" to cook its French fries, Mr. Sharma joined the legions of Hindu Americans and vegetarians who began venturing into McDonald's to nibble what they believed were vegetarian fries. Mr. Sharma's teenage son even took a job at McDonald's last year, and drawn by the generous employee discount, the Sharma family consumed countless bags of fries.

So Mr. Sharma said he was horrified when he opened his India West newspaper in April and read, "Where's the Beef? It's in Your French Fries." He and other American Hindus were outraged to learn that McDonald's French fries are seasoned in the factory with beef flavoring before they are sent to the restaurants to be cooked in vegetable oil.

Now Mr. Sharma is one of three plaintiffs representing the Hindus and vegetarians of America in a lawsuit filed on May 1 in Seattle that accuses McDonald's of deliberately misleading its American customers.

"I feel sick in the morning every day, like I want to vomit," Mr. Sharma said in a recent interview. "Now it is always there in my mind that I have done this sin."

The news ricocheted to India, where restaurant windows were smashed, statues of Ronald McDonald smeared with cow dung, and Hindu nationalist politicians called for the chain to be evicted from the country. In Fiji, a majority of Hindus and vegetarians told pollsters they had heard about the beef in the fries and stopped eating at McDonald's.

McDonald's, a corporation that prides itself on catering to the culinary requirements of ethnic and religious groups in its restaurants overseas, says it uses no animal extracts in the French fries it sells in India and in Fiji, where nearly half the population is of Indian descent. A test of the French fries by an Indian organization after the rioting confirmed the claims of the company, which says it is going forward with plans to expand in India.

McDonald's says it never said that the French fries sold in the United States were vegetarian. The marketing campaign proclaiming the switch to vegetable oil in 1990 was "all about healthy hearts and eliminating cholesterol," Walt Riker, a spokesman for McDonald's, said in an interview last week. "We certainly don't market ourselves as vegetarian."

He said McDonald's added beef flavoring to the fries before they were flash frozen, and complied with Food and Drug Administration regulations by saying that it included "natural ingredients," without specifying what they were. And although McDonald's may re-evaluate its labeling policies, Mr. Riker said, it does not intend to alter its recipe.

"These are the ways the fries are made in the U.S., and we don't have any plans to change," Mr. Riker said.

Burger King and Wendy's restaurants do not use beef products in their French fries, their corporate spokesmen said in interviews on Thursday.

Vegetarian groups had suspected there was beef flavoring in McDonald's French fries and petitioned the company and the Food and Drug Administration for full disclosure of ingredients with no success. Fast- food restaurants are highly secretive about their recipes, and it was only after the lawsuit was filed that McDonald's spokesmen widely acknowledged the beef ingredient.

"They would post these lists of their ingredients in their stores, but nowhere did they ever publicly admit that beef flavoring was used in the fries," said James Pizzirusso, who founded the Vegetarian Legal Action Network with other law students at George Washington University.

"Corporate America needs to pay attention to consumers who avoid certain food products for religious or health reasons, or because they have allergies," he said. "They say they are complying with the law in terms of disclosing their ingredients, but they should go beyond the law." Vegetarian advocacy groups claim to represent as many as 15 million Americans. And while those groups are accustomed to confronting American corporations, the lawsuit is a watershed for the Hindus in the United States. Mostly first- and second-generation immigrants from India, with a smattering of American converts, they are estimated to number more than one million people. Until now, they have put far more effort into educating their children and building temples to perpetuate their religion than into pressuring the federal government or industry to accommodate their customs.

The lawsuit came about when the vegetarian law students connected with the outraged Hindus.

The students at George Washington University had drafted the legal complaint as a project for a class on legal activism, and were looking for a lawyer to file it. In Seattle, Harish Bharti, a Hindu lawyer, read about the secret ingredient in the article in India West and decided to sue.

India West heard about the ingredient from Hitesh Shah, a Los Angeles software engineer and a strict vegetarian. He had sent an e-mail inquiry about French fries to McDonald's, and received a reply from a customer service representative who wrote that McDonald's used "a minuscule amount of beef flavoring as an ingredient in the raw product."

Mr. Bharti called Lige Weill, executive director of the Vegetarian Awareness Network in Knoxville, Tenn. Mr. Weill had already succeeded in getting the Wendy's chain to stop putting gelatin (made of animal collagen) into the sauce on its Fresh Stuffed Garden Veggie Pita.

Mr. Weill introduced the students to Mr. Bharti, who had been in the news for suing corporations and defending battered women. Mr. Bharti also teaches trial skills at the Gerry Spence College for Trial Lawyers in Wyoming. "I see this as a fight for the dharma," said Mr. Bharti, using the Sanskrit word that loosely translated means "ultimate principles."

"Eating a cow for a Hindu would be like eating your own mother," he said. "People have told me, `I would rather die here than go to McDonald's.' " In the last 10 days, he has filed additional lawsuits against McDonald's in California and in Canada.

In the Indian-American neighborhoods of Chicago and Houston, in the sari shops and vegetarian restaurants, many Hindus said they had heard about the lawsuit, but not all said they agreed with it.

Parag Gandhi, 32, the manager of the Taj Sari Palace in northwest Chicago, said he considered himself "a McDonald's man," and thought the Hindu plaintiff foolish. "I don't think Ronald McDonald walked up to him and made him eat the French fries," Mr. Gandhi said. "People should know that if they are eating at a place that serves meat products that they have to be more than careful if they don't want to eat meat. Come on, I mean it's McDonald's."

At the Anand Bhavan Vegetarian restaurant in Houston, Mahendra Jagirdar, an engineer, said he had stopped eating at McDonald's when he heard about the fries. "I'm a pretty strict vegetarian," he said. "That's why I like a place like this where I don't have to compromise."

As for Mr. Sharma, the plaintiff in Seattle, he is seeking ways to cleanse himself. "I am now planning to go to India to take a dip in the Ganges," said Mr. Sharma, the grandson of a Hindu religious counselor to a maharajah. "I am thinking that it should reduce my sin. But the damage is already done."

Washington, D.C. (SafetyAlerts) -  The FDA is advising consumers of an outbreak of foodborne illness associated with cantaloupe from two Mexican companies, S.P.R. De R.I. Legumbrera San Luis and S.P.R. De R.I. Los Arroyos, and imported by Shipley Sales Service of Nogales, Arizona. This outbreak of Salmonella poona has involved numerous illnesses and two deaths in Arizona, California, Connecticut, Georgia, Hawaii, Massachusetts, Minnesota, Missouri, New Mexico, Nevada, New York, Oregon, Tennessee and Washington state.

Salmonella poona 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 poona often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection 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 cantaloupe was sold in retail stores and restaurants and possibly served in health care facilities. Fresh cantaloupe has a shelf life of 14-18 days.

As a result of this investigation, FDA has taken steps to prevent the importation of any other contaminated cantaloupe. FDA is detaining all cantaloupe imported by Shipley Sales Service from S.P.R. De R.I. Legumbrera San Luis and S.P.R. De R.I. Los Arroyos.

FDA, States and other government agencies are continuing to investigate this matter. Retailers, restaurants and food service operations should determine if any of their existing stock of cantaloupe was purchased or sold under the Viva brand name, and if so, remove from sale. Any cantaloupe bearing this brand name should not be consumed.

Although Viva is the only brand associated with this outbreak, FDA continues to recommend that consumers take the following steps with cantaloupe and other produce to reduce the risk of foodborne illness. This supports advice given by the state of California.

Purchase produce that is not bruised or damaged. If buying fresh cut produce, be sure it is refrigerated or surrounded by ice.

After purchase, put produce that needs refrigeration away promptly.  (Fresh whole produce such as bananas and potatoes do not need refrigeration.) Fresh produce should be refrigerated within two hours of peeling or cutting. Leftover cut produce should be discarded if left at room temperature for more than two hours.

Wash hands often. Hands should be washed with hot soapy water before and after handling fresh produce, or raw meat, poultry, or seafood, as well as after using the bathroom, changing diapers, or handling pets.

Wash all fresh fruits and vegetables with cool tap water immediately before eating. Don't use soap or detergents. Scrub firm produce, such as melons and cucumbers, with a clean produce brush. Cut away any bruised or damaged areas before eating.

Wash surfaces often. Cutting boards, dishes, utensils, and counter tops should be washed with hot soapy water and sanitized after coming in contact with fresh produce, or raw meat, poultry, or seafood. Sanitize after use with a solution of 1 teaspoon of chlorine bleach in one quart of water.

Don't cross contaminate. Use clean cutting boards and utensils when handling fresh produce. If possible, use one clean cutting board for fresh produce and a separate one for raw meat, poultry, and seafood. During food preparation, wash cutting boards, utensils or dishes that have come into contact with fresh produce, raw meat, poultry, or seafood. Do not consume ice that has come in contact with fresh produce or other raw products.

Use a cooler with ice or use ice gel packs when transporting or storing perishable food outdoors, including cut fresh fruits and vegetables.

Middletown, CT (SafetyAlerts) - Vital Nutrients/RHG & CO., Inc is voluntarily recalling dietary supplement products named VITAL NUTRIENTS JOINT EASE (both 60 and 120 count) and VERIFIED QUALITY JOINT COMFORT COMPLEX (both 60 and 120 count), ALL LOT NUMBERS because it contains Clematis Chinensis Extract, which contains Aristolochic Acid. Consumption of products containing Aristolochic Acid have been associated with life threatening adverse risks and is considered a potent carcinogen and nephrotoxin.

JOINT EASE/JOINT COMFORT COMPLEX was distributed to the following states; AK, CA, CO, CT, FL, HI, IL, MA, MT, NC, NH, NJ, NV, NY, OR, TX, VT, WA through distributors, direct delivery, retail stores and Naturopathic Physicians, Chiropractic Physicians and MD’s.

Product can be identified through labels - Vital Nutrients Joint Ease and Verified Quality Joint Comfort Complex (both 60 and 120 count bottles).

The FDA has received reports that two patients in the U.S. developed serious kidney disease associated with the use of botanical products that were shown by laboratory analysis to contain aristolochic acid.

The voluntary recall was initiated after Vital Nutrients identified an independent laboratory that was capable of conducting the appropriate analysis to determine the presence of aristolochic acid in Clematis Chinensis Extract - the results were positive for aristolochic acid. The production and distribution of these products was suspended by Vital Nutrients.

Consumers who purchased the products are urged to return them to the place of purchase for full refund. Consumers who purchased these products directly from Vital Nutrients can call for specific return instructions. Consumers with questions may contact Vital Nutrients at 888-328-9992.

Notice of this product warning was sent via email to SafetyAlerts subscribers May 25, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

Wilbraham, MA (SafetyAlerts) - Friendly Ice Cream Corporation is voluntarily recalling its half gallon packages of all varieties of "Candy Shoppe® Sundae" ice cream because they may contain undeclared egg whites. People who have allergies to egg whites may have an allergic reaction, including a serious or life-threatening allergic reaction, if they consume these products.

The recalled "Candy Shoppe® Sundae" products were distributed in supermarkets, convenience stores and Friendly's Restaurants in the states of MA, ME, RI, CT, VT, NH, NY, NJ, PA, OH, VA, MD, DC, FL, TN, IN, WV, MI, NC and SC.

The products come in a half-gallon package marked with an expiration date prior to March 4, 2002, embossed in the form of "04Mar02" or "Mar0402" (or earlier) or inkjet printed in the form of "25-26 WC5 020304 (these six digits indicate Year-Month-Day) 00000" or earlier. To date, one minor reaction following consumption of the product has been reported.

The company initiated the recall after it was discovered that the egg white containing product was distributed in packaging that did not reveal the presence of egg whites. Subsequent investigation indicates the problem was caused by an error in the company's package printing process that has since been corrected.

Consumers who are allergic to egg whites and have purchased half-gallon packages of "Candy Shoppe® Sundae" ice cream may return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-723-1591.

Notice of this product warning was sent via email to SafetyAlerts subscribers May 25, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

Washington, DC (SafetyAlerts) - The FDA is warning consumers not to purchase or use Pierre Fabre Physicians Formula Eye Makeup Remover Lotion because it may be contaminated with Pseudomonas fluorescens and/or Pseudomonas putida, bacteria that can cause severe, sight-threatening infections of the cornea. The manufacturer, Physicians Formula Cosmetics of Azusa, California, a subsidiary of Pierre Fabre, Inc. is voluntarily recalling 16,300 bottles of the product.

This product was distributed nationwide through retail stores, pharmacies, and supermarkets from March 14 though May 28, 2001.

This product is sold in 2 oz. bottles with #698 the on the back of the label and batch numbers #0821 or #0601 imprinted on the bottom of the bottle. No injuries or adverse events have been reported to date in connection with this problem.

The recall was the result of a routine sampling program by the company which revealed that the finished products contained the bacteria.

Consumers who have used this product should contact their physician if they experience any problems with their eyes. Individuals who have purchased Physicians Formula Eye Makeup Remover Lotion are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-227-0333.

Notice of this product warning was sent via email to SafetyAlerts subscribers June 11, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.
 

White Plains, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Snapple Beverage Group has recalled certain Snapple Diet Cranberry Raspberry because the product may be contaminated with mold.

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

PRODUCT
Snapple Diet Cranberry Raspberry beverage in 16 ounce glass bottles, 24 btls per case.

Recall # F-431-1.

CODES:
Case code FEB-19-01 RC; Bottle code CT735 19B1.

MANUFACTURER:
Beverage Capital Corporation, Baltimore, MD.

RECALLED BY:
Snapple Beverage Group, White Plains, NY, by telephone beginning on 3/15/01. Firm initiated recall is *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:
NY, PA, MD, NH, NJ, DE, CT, MN and MI.

QUANTITY:
11457 cases.

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

Brooklyn, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that B&B International Connections has recalled certain Pathrop brand preserves because the products were labeled as sugar free when they contained sugars. Additionally the Cranberry and Mountain cranberry flavors contained undeclared sodium benzoate.

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

PRODUCT
Pathrop brand preserves:
a) Raspberry Sugar Free preserve in glass jars.
Recall # F-403-1.

b) Cranberry Sugar Free Preserve in glass jars.
Recall # F-404-1.

c) Mountaine Cranberry Sugar free preserve in glass jars.
Recall # F-405-1.

CODES:
a) Raspberry:            UPC 601622 000698
b) Cranberry:             UPC 601622 000674
c) Mountaine Cranberry:     UPC 601622 000674

MANUFACTURER:
Ratibor, Moscow, Russia.

RECALLED BY:
B&B International Connections, Brooklyn, NY.

DISTRIBUTION:
NY, and MA.

QUANTITY:
86 cases.

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

Virginia Beach, VA (SafetyAlerts) - Stihl Inc. is voluntarily recalling about 1,000 chain saws because a missing screw can cause the chain brake to fail to operate, presenting a laceration hazard to consumers.

The recalled chain saws are model number 019T with serial numbers 249129398 through 249956311. A label on the chain saw reads in part "STIHL" and "model number 019T." The serial number is imprinted on the front of the chain saw. Stihl dealers sold the chain saws from December 2000 through May 5, 2001 for about $270.

No injuries have been reported.

Consumers should stop using the recalled chain saw immediately and return it to the Stihl dealer where purchased for repair. For more information, contact Stihl Inc. at (800) 467-8445 8 a.m. to 5 p.m. Monday through Friday.

Carson, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Leiner Health Products, Inc. has recalled certain Enteric Coated Aspirin Tablets because of dissolution failure (18 month stability).

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

PRODUCT
Enteric Coated Aspirin Tablets, 325 mg. under the Pharmacist Formula and Hannaford labels in 100 tablet bottles.

Recall # D-237-1.

CODES:
Lot 0A01453.

MANUFACTURER:
LNK International Hauppauge, NY.

RECALLED BY:
Leiner Health Products, Inc., Carson, CA, by letter on 5/16/01. Firm initiated recall is ongoing.

DISTRIBUTION:
FL, IL, MD, ME, VT, and VA.

QUANTITY:
18,888 bottles.

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

Cleveland, TN (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Schering-Plough HealthCare Products has recalled certain Lotrimin AF Spray Liquid because it is misbranded; Lotrimin AF Liquid Spray was incorrectly labeled as Lotrimin AF Deodorant Powder.

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

PRODUCT
Lotrimin AF Spray Liquid, 4 oz. (113 gram) Aerosol can, The product is an OTC, topically applied antifungal aerosol. The active ingredient is 2% Miconazole Nitrate.

Recall # D-221-1.

CODES:
Lot Number 1A05CC. 1A05CCC Exp 01 04.

MANUFACTURER:
CCL Custom Manufacturing, Inc. Cumberland, RI.

RECALLED BY:
Schering-Plough HealthCare Products, Cleveland, TN., by letter dated May 22, 2001. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
96,500 units (individual cans).

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

Orange, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that two different companies have recalled certain Serostim Vials because the drug is counterfeit.

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

PRODUCT
Serostim Vial, 6 mg, (somatropin (rDNA origin) for injection), NDC 44087-0006-07, cartons of 7.

CODES:
Lot No: MNK612A.

RESPONSIBLE FIRM AND MANUFACTURER:
Unknown.

RECALLED BY:
BERGEN BRUNSWIG DRUG CO., Orange, CA, by recall letter dated March 8, 2001. Firm initiated recall is ongoing. Recall # D-224-1.

DISTRIBUTION:
CA, HI, MD, TX, and WA (mostly in CA).

QUANTITY:
9,998 VIALS.

ALSO RECALLED BY:
C & H Wholesale, Inc., Davie, FL, by letter dated Jan 25, 2001. Firm-initiated recall complete.  Recall # D-223-1.

DISTRIBUTION:
NJ and FL.

QUANTITY:
36 boxes.

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

Murray Hill, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that BOC Gases has recalled certain Oxygen Tanks.   FDA sited the reason for the recall as follows; "MISBRANDED; Liquid Oxygen DEWAR (TWO LABELS-OXYGEN/NITROGEN) with non-permanent fittings involved in deaths."

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

PRODUCT
Oxygen, USP, Liquid, 196 Liter Dewars (Tanks).

Recall # D-230-1.

CODE:
Lot #:                        Exp. Date

333F001                  28NOV2001
333F002                  28NOV2001
333F003                  28NOV2001
334F001                  29NOV2001
334F002                  29NOV2001
334F003                  29NOV2001
340H001                  05DEC2001
340H002                  05DEC2001
340H002                  05DEC2001
341F001                  06DEC2001
341F002                  06DEC2001
341F003                  06DEC2001

MANUFACTURER:
BOC Gases, Dayton, OH.

RECALLED BY:
BOC Gases, Murray Hill, NJ., by telephone on December 7, 2000. Firm-initiated recall ongoing.

DISTRIBUTION:
OH.

QUANTITY:
12 cylinders.

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

Passaic, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Square Enterprises Corporation has recalled certain Mieszko brand Galaretka w Czekoladzie because the products contained the unapproved color additives Ponceau 4R and quinoline yellow.

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

PRODUCT
a) Mieszko brand Duet Galaretka w Czekoladzie (chocolate candy with jelly and marshmallow filling) in bags with net wt. 220 g/ 7.74 oz. Recall # F-432-1.

b) Mieszko brand Trio Galaretka w Czekoladzie (chocolate candy with jelly filling) in bags with net weight 200 g/7.04 oz.  Recall # F-433-1.

CODE:
All codes on the market at the time the recall was initiated.

MANUFACTURER:
Z.P.C. Mieszko S.A. Raciborz, Poland.

RECALLED BY:
Square Enterprises Corporation, Passaic, NJ.

DISTRIBUTION:
NJ, NY, CT, and PA.

QUANTITY:
Duet 220gm -- 550 cases; Trio 220gm -- 550 cases (15 bags/case).

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

Holland, OH (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Steiner Company Inc. has recalled certain Hair & Body Shampoo because the product contains the unapproved color additives C.I. Acid Blue #1, C.I. Acid Green #25, and C.I. Acid Yellow # 23.

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

PRODUCT
Hair & Body Shampoo, packed in 800 ml bags (inside a box), for use in the Bag-In-Box dispensers, 12 per case.

Recall # F-430-1.

CODE:
The following batch codes are recalled [all batches]: C032071, C031281, C060881, C073181, CC111781, C071291, C192191, C060101, and C091501.

MANUFACTURER:
Steiner Company, Inc., Holland, OH.

RECALLED BY:
Manufacturer, by facsimile 4/2/2001. Firm initiated recall is *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:
IL.

QUANTITY:
1,313 cases.

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

Detroit, MI (SafetyAlerts) - The Food and Drug Administration (FDA) said today that The Coca-Cola Bottling Company of Michigan has recalled Diet Coke because the product actually contains regular Coca Cola Classic which contains sugar not declared on the Diet Coke label.

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

PRODUCT
Diet Coke brand Coca Cola in 20 Fl Oz. bottles.

Recall # F-437-1.

CODE:
The Optimum taste Date Code is JUN1101DTD21:40-21:55.

MANUFACTURER:
The Coca-Cola Bottling Company of Michigan, Detroit Production Facility, Detroit, MI.

RECALLED BY:
Manufacturer, by letter dated 3/30/01. Firm initiated recall is *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:
Detroit, MI.

QUANTITY:
184 cases.

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

Chicago, IL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Sara Lee Bakery has recalled certain KFC Little Bucket Parfait Lemon Cream because the product contains undeclared FD&C Yellow No. 5 Lake.

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

PRODUCT
KFC Little Bucket Parfait Lemon Cream, SKU 5453; Net Wt. 4.5 oz. (127 g); Sara Lee Bakery, Chicago, IL 60604 U.S.A. Conn. Lic. 3610 P-546604-007; 48/4.5 oz. cups per case.

Recall # F-434-1.

CODE:
All "Use By" dates before April 30, 2002. The "Use By' date appears on the outer shipping case of 48 cups.

MANUFACTURER:
Sara Lee Bakery, Traverse City, MI.

RECALLED BY:
Sara Lee Bakery, Chicago, IL, by telephone on 5/15 and 16/01 and letter on 5/17/01. 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:
MS, MI, IL, OH, WI, OK, FL, TX, NC, GA, KY, VA, TN, CA, KA, SC, CO, UT, AZ OR, MT, AL.

QUANTITY:
38,598 cases.

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

Wellsville, PA (SafetyAlerts) - Ken Weaver Meats, Inc. is voluntarily recalling approximately 5,000 pounds of sausage products that may be contaminated with drug residues, the U.S. Department of Agriculture’s Food Safety and Inspection Service has announced.

The products being recalled are:

Whole-ring and half-ring packages of WEAVER’S OF WELLSVILLE RING BOLOGNA.
WEAVER’S OF WELLSVILLE HOT SMOKED SAUSAGE.
WEAVER’S OF WELLSVILLE BUTCHER BOLOGNA.
WEAVER’S OF WELLSVILLE SUMMER SAUSAGE (TURKEY ADDED).

FSIS residue sampling detected penicillin, an antibiotic, and sulfadimethoxine, an antimicrobial, in ingredients used to produce the bologna.

The products were produced between May 8 and June 10 and distributed to wholesale and retail establishments in Adams, Cumberland, Dauphin, Perry, and York counties in Pennsylvania.

"We urge consumers to check their refrigerators and freezers," said Margaret O’K. Glavin, acting FSIS administrator. "If they find the recalled products or have purchased the products at local delis, consumers should not eat them, but return them to the point of purchase."

FSIS has received no reports of illnesses or adverse reactions associated with consumption of this product. Anyone with a medical concern should contact a physician.

Consumers and media with questions about the recall may contact Craig Weaver, company secretary, at (717) 432-4146.

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.

Piscataway, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Enzon, Inc, is recalling certain ADAGEN (pegademase bovine injection) because of cross contamination with FOMEPIZOLE (4-METHYL-PYRAZOLE).
ADAGEN:Pegademase (peg-A-de-mase) contains an enzyme called adenosine deaminase (ADA). It is used to treat children who do not have a properly developed immune system because of a lack of ADA in the body.
 This is the first public notice of this Class II recall issued by FDA.

RECALL NUMBER, PRODUCT AND CODE
D-240-1, ADAGEN (pegademase bovine injection) 250 units per mL.
Intramuscular use only 1.5 mL single-dose vials (units of 4) Rx only.
NDC 57665-001-01
NDA 19-818

MANUFACTURER
Enzon, Inc, Piscataway, NJ

RECALLED BY:
Manufacturer, on March 23, 2001, by telephone.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
CA, FL, IL, LA, MD, MA, NY, NC, OH, OK, TN, TX, UT and including Japan, Australia, Canada, Denmark, Croatia, France, Germany, Italy, Switzerland, and Spain.

QUANTITY
792 vials.

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

KDDI, the Japanese telecommunications group, is to recall more than half a million mobile phones made by Sony because of a production flaw.

The recall of 560,000 handsets used by KDDI's "au" service is one of Japan's largest to date, and could force it to cut prices in a bid to rebuild its reputation. Matsushita Communication Industrial, which uses the Panasonic brand, has been forced to discount handsets heavily since recalling 230,000 phones in February.

The move comes less than three months after Sony re-entered the mobile phone market through a $500m alliance with Ericsson of Sweden, reversing a humiliating withdrawal from the US.

Masahiro Ono, UBS Warburg electronics analyst, warned Sony's brand image would be hurt as it prepared for next generation mobile phones with Ericsson. "It will affect their business in the future," he said.

Sony has suffered two other recalls in recent months. In May, NTT DoCoMo, the leading mobile carrier, recalled 420,000 Sony-made handsets because of a software bug and KDDI recalled 126,000.

The DoCoMo recall cost Sony Ą12.6bn ($100m), or Ą30,000 for each phone, because each unit had to be replaced. Mr Ono estimated that the repair cost for this recall, which involves only changing the battery pack, would be about Ą3,000 for each unit or Ą1.68bn.

Mr Ono said the two incidents could force Sony to revise down its profits forecast unless it offset the cost with additional extraordinary sales or a reduction in expenses. Sony declined to comment on the financial impact of the recall.

But analysts said the recall would have little effect on KDDI. Atsuo Takahashi, telecommunications analyst at ABN Amro, said the phones represented only about 5 per cent of au subscribers and were likely to be replaced quickly.

While earlier recalls involved software bugs on internet-enabled phones, the latest affects the battery pack attached to the back of the C460 series handsets, which first went on sale in January.

Although Sony did not make the lithium ion battery itself - it is understood to have been outsourced, - Sony was responsible for the final assembly of the battery with a plastic covering. During this process, solder debris entered the battery pack, which caused the handset to overheat in some cases.

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Friday asked makers of dietary supplements containing the herb comfrey to withdraw their products due to the danger of liver damage and its possible role as a cancer-causing agent.

In a letter to industry groups representing herbal product makers, the FDA said it was aware of dietary supplements derived from three types of comfrey that contain toxic alkaloids.

The agency strongly recommends that firms marketing a product containing comfrey, or another source of pyrrolizidine alkaloids, remove the product from the market and alert its customers to immediately stop using the product," FDA said.

In addition to being toxic to the liver, 'there is also evidence that implicates these substances as carcinogens," the FDA said.

The FDA does not regulate dietary supplements as closely as drugs but can pull supplements from the market if it can demonstrate sufficient risk.

"This came to that point," said Christine Lewis, FDA director of nutritional products and dietary supplements. Lewis told Reuters the agency was gathering evidence on a number of other herbal products which she declined to identify.

The Council for Responsible Nutrition (CRN), one of the recipients of the FDA letter, said most herbal supplement manufacturers had been aware since at least 1996 of comfrey's dangers if taken internally or used on broken skin.

John Cardellina, the council's vice president of botanical science, said the FDA's action was welcome as long as the message was put in perspective. "It's not like there's an enormous amount of this product out there that is wildly dangerous," he said.

Separately the Federal Trade Commission (FTC) announced action on Friday against an Internet marketer of comfrey remedies.

Utah-based Christopher Enterprises Inc. agreed to a preliminary injunction that bars the company from marketing products containing comfrey "for internal uses or on open wounds," the commission said.

Christopher Enterprises sold comfrey products as a cure for maladies ranging from asthma and tuberculosis to broken bones and herpes, the consumer watchdog said.

The commission said the company falsely claimed it was safe to take comfrey products orally or as suppositories or to apply them to open wounds.

NOTE: This recall is due to the SPANISH label on the formula, it does NOT AFFECT consumers using the English instructions printed on the front of the instruction label.

Evansville, IN (SafetyAlerts) - Mead Johnson Nutritionals is recalling about 3.7 million 16 -ounce cans of powder Nutramigen formula, and about 930,000 32-ounce cans of the ready-to-use version of the product because the cans have incorrect preparation instructions, in Spanish, that could lead to serious health problems and even death, according to the U.S. Food and Drug Administration.

The cans carry a two sided label with English instructions on the front and Spanish on the rear - the SPANISH SIDE provides incorrect instructions which can lead to serious health problems including seizures, irregular heartbeat and even death.

English instructions printed on the cans have the correct instructions printed on them.

No reports of any infants sickened because of the labeling error have been received, but parents should contact a doctor if a child has become ill after eating the product. Symptoms to look for include vomiting, diarrhea, irritability, less urination, decreased activity and sunken eyes, according to a company press release.

The product was distributed nationwide and in Guam, the Dominican Republic and Puerto Rico.

The recalled Nutramigen cans are white with blue lettering and have pictures of rabbits on the side. The cans were sold in six-packs and have the following batch codes:

-For powder formula, the bottom of the can reads: BHC43, BHC44, BJC45, BJC46, BJC47, BJC48, BKC49, BKC50, BLC51, BLC52, BLC53, BMC54, BMC55, BMC56, BAM57, BAM58, BBM59, BBM60, BBM61, BCM62, BCM63, BCM64, BDM65, BDM66, BEM67, BEM68, BEM69, BEM70, BEM71, BEM72, BFM73 and BFM74.

-For ready-to-use formula, the top of the can reads: MBM90, MBM91, MCM92, MCM93, MCM94, MDM95, MDM96, MEM97, MFM00 and MFM01.

Consumers can use the proper preparation instructions or return the cans to the place of purchase for a full refund. For more information consumers should call Mead Johnson toll-free at 1-800-718-7725 between 7 a.m. and 7:30 p.m. CDT Monday to Friday and on Saturday between 8 a.m. and 4:30 p.m. CDT.

For cans still on store shelves, the company will place stickers on them telling consumers to ignore the Spanish instructions, according to the company press release.

OTTAWA, July 11, 2001 - The Canadian Food Inspection Agency (CFIA) is warning consumers with allergies to peanut protein, tree nut proteins, milk protein, egg protein or wheat protein not to consume E. Wedel brand chocolate products imported from Poland. These products may contain various allergens that are not declared on the label. This alert is of concern to those individuals who have allergies to these allergens. The CFIA is expanding a warning issued on June 16, 2001 and its update on June 21, 2001 related to E. Wedel products.

All chocolate products bearing the brand name E. Wedel and UPC code 5 901588 are affected by this recall if they do not clearly indicate on the label all of the following allergens - peanut, tree nuts, milk, egg and wheat. E. Wedel products which have partial precautionary statements, such as "May contain peanuts" or "May contain peanuts and other nuts" are also affected.

The affected products are made by Cadbury Wedel, Poland and imported by various importers in Canada. These products may include bitter chocolates, filled chocolates, milk chocolates, plain chocolate and chocolate deserts. The names of the product on the label may appear in Polish. These products may be distributed nationally.

Consumption of these products may cause a serious or life-threatening reaction in persons with allergies to peanut protein, tree nut proteins, milk protein, egg protein or wheat protein. There have been no reported illnesses associated with the consumption of these products.

For more information, consumers and industry can call the CFIA at the following numbers:

In the province of Quebec 1-800-561-3350
In other provinces and territories 1-800-442-2342

For information on receiving recalls by electronic mail, or for other food safety facts, visit our web site at www.inspection.gc.ca

OTTAWA, November 13, 1998 -- The Canadian Food Inspection Agency is warning consumers with allergies to peanuts not to eat imported chocolate bars sold under the brand name E. WEDEL which are manufactured in Poland. These products may contain peanut which is not declared on the label.

The chocolate bars being recalled include all lot numbers and sizes of flavours which do not declare peanuts in the list of ingredients. The attachment lists products affected by the recall. Other flavours not covered by the list may also be affected.

Consumption of these products is of concern only to those who are allergic to peanut. There have not been any reported illnesses associated this these products. The recalled product has been distributed across Canada with the exception of the Atlantic Provinces.

The importer, Ewa Trading International Inc. of Concord, Ontario, is recalling the products from the marketplace. For more information regarding the products, consumers may contact Tanya Desyatnik at Ewa Trading International at (905) 660-6502.

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

or more information, contact:

Dave Brown
Canadian Food Inspection Agency
Ottawa
(613) 225-2342 Ext. 3805
Pager (613) 760-0570

PRODUCT LIST
Mocca Chocolate
Chocolate Bar Pawelek Toffi
Chocolate Bar Pawelek Strawberry
Chocolate with Orange Filling
Milk Chocolate with Coconut Filling
Chocolate with Toffee Filling
Chocolate with Milk Filling
Milk Chocolate with Strawberry Filling
Chocolate with Walnut Filling
Milk Chocolate
DESEROWA Chocolate
JEDYNA-Bitter-Sweet Chocolate
KREMOKA Chocolate
Milk Chocolate with Hazelnut
Milk Chocolate with Hazelnut Filling
Luxury Milk Chocolate with Hazelnut
Bitter Chocolate
Other flavours not covered by the list may also be affected.

Oakmont, PA (SafetyAlerts) - ATF Fitness Products, Inc. is recalling BioPharm brand T-Cuts, a dietary supplement, because it contains tiratricol, also known as triiodothyroacetic acid or TRIAC, a potent thyroid hormone that may cause serious health consequences including heart attacks and strokes.

The T-Cuts was distributed nationwide to retail stores or mail order. T-Cuts is packaged in 90-count capsules in white bottles with black lettering. All lot numbers are affected by this recall.

No illnesses have been reported to date. This recall is being conducted with full knowledge of the U.S. Food and Drug Administration.

ATF Fitness Products, Inc. urges all individuals who may have purchased this product, or any product containing tiratricol, to stop using them immediately and, in addition, to consult their health professional if they are experiencing any adverse effects, which may include insomnia, nervousness, sweating, and diarrhea.

Consumers who have purchased this product are urged to return it to the place of purchase for a full refund. Consumers with questions may contact ATF Fitness Products, Inc. at 1-800-468-5017.

Brooklyn, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Adamba Imports International Inc. is recalling certain Muszelki Chocolate Filled Candy Walnut Flavor because they contain undeclared peanuts.

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

PRODUCT:
Muszelki Chocolate Filled Candy Walnut Flavor packed in flexible plastic packages, net wt. 8 oz., product of Poland. There are 48 - 8 oz. packages per case. (Note: This product was distributed in 1997.)

RECALL NUMBER: F-443-1

The product was not coded but can be identified by barcode # 0 76841 01273 1.

REASON:
New York State Department of Agriculture and Marketsí analysis found that the product contained undeclared peanuts.

MANUFACTURER:
Unknown

RECALL BY:
Adamba Imports International Inc., Brooklyn, NY via press release and telephone beginning on 4/28/00. The firm additionally sent recall letters on 5/19/00.

STATE 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:
NY, CA, WA, PA, CT, MA, MD, NJ

QUANTITY:
823.5 cases (48 - 8 oz. packages per case) of product

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

FDA today announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision.

Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as “statins.” Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.

Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.

Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body. Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal.

Bayer Pharmaceutical Division has announced plans to recall Baycol to the pharmacy level. Pharmacies will be instructed to return the product to the manufacturer for a refund.

Patients who are taking Baycol should consult with their physicians about switching to alternate medications to control their cholesterol levels. Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician.

There are five other statins available in the U.S. that may be considered as alternatives to Baycol. They are: lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin (Lipitor).
For further information regarding the withdrawal of Baycol, patients and physicians can contact Bayer Customer Service 1-800-758-9794 or the FDA’s Drug Information Office at 301-827-4573 or 1-888-INFO-FDA.

Bayer A.G., the German pharmaceutical and chemical conglomerate, voluntarily withdrew Baycol, its highly profitable cholesterol-lowering drug, from the world market yesterday. Thirty-one patients have died while taking it, the company reported, because the drug caused an unusual condition in which muscle tissue broke down.

The United States Food and Drug Administration "agrees with and supports this decision," the agency said. It said pharmacists would be instructed to return the drug to Bayer for refunds. The F.D.A. approved Baycol for use in the United States in 1997.

Though other drugs in its class, called statins, have been linked to muscle cell damage in rare cases, the problem is much more common with Baycol than with other such drugs, said Dr. John Jenkins, the director of the office of drug evaluation at the F.D.A.

Statins are wildly popular drugs taken by millions of Americans. They make cholesterol levels plummet by blocking an enzyme required in its synthesis. Since the first statins were introduced in the late 1980's, they have revolutionized the treatment of high cholesterol levels.

From the beginning, medical experts said, statins were known to cause the muscle problem, rhabdomyolysis, which can lead to kidney failure and other problems. But it occurred very rarely and was almost never fatal. Dr. Scott Grundy of the University of Texas Southwestern Medical Center in Dallas said that as far as he knew, there was not a single death from rhabdomyolysis in clinical trials where 50,000 patients were carefully studied.

With Baycol, however, reports of serious rhabdomyolysis were about 10 times as frequent as with the other statins, Dr. Jenkins said.

"Baycol really stood out as being different," he said. "Baycol did not offer any benefits beyond those of the other statins. But it carried a potential risk, and that leads to a conclusion that it is no longer safe to be marketed."

The Baycol deaths tended to occur in patients taking higher doses of the drug and in those taking it along with gemfibrozil, a nonstatin drug that also lowers blood triglycerides.

Dr. Jenkins said patients taking Baycol should consult with their doctors about taking another drug instead. Any patients taking Baycol and experiencing muscle pain, or taking Baycol along with gemfibrozil, should immediately stop taking Baycol and consult with their doctors, he added.

Bayer said it was withdrawing the medicine from markets throughout the world except for Japan, where gemfibrozil is not available. The company said using the two drugs together was "contraindicated," meaning that doctors were not supposed to prescribe both.

Dr. Claude Lenfant, director of the National Heart, Lung and Blood Institute, said two of his own children were taking statins. If they asked him if they should stop, he said, "I would say no."

The problems with Baycol may prove devastating for Bayer, and the company's withdrawal of its drug shocked investors. Bayer predicted that the loss of Baycol would reduce its revenues this year by as much as $572 million.

Last year, the drug generated $554 million in sales and Bayer had predicted that sales would top $800 million this year. The drug's biggest competitors are two older statins, Lipitor from Pfizer and Zocor from Merck, which together account for about 80 percent of sales in anti cholesterol drugs.

Bayer's position in the global pharmaceutical industry was already shaky. Bayer is one of the last old- style conglomerates trying to be major competitors in both the pharmaceutical and chemical industries. Most of its big rivals, from DuPont in the United States to BASF and Aventis in Europe, have chosen to focus on one industry and sell the other. Bayer's pharmaceutical business is far smaller than the industry leaders'.

The withdrawal of Baycol was the latest in a string of problems that leave Bayer with few promising new drugs on the market and even fewer in the pipeline for the next few years. Several weeks ago, the Food and Drug Administration ordered Bayer to shut down production of Kogenate, a fast-growing medication for hemophilia, because of contamination problems, and the company halted clinical trials for what it had billed as a major new asthma drug.

"Bayer is now very, very weak in comparison to other pharmaceutical companies," said Martin Roediger, a pharmaceutical analyst at DG Bank in Frankfurt, which lowered its rating for Bayer shares to "sell" from "reduce."

Bayer's shares plunged nearly 17 percent yesterday, dropping 7.4 euros to 37.41 euros in Frankfurt.

Firma Leverkusen-Bayer w trybie natychmiastowym wycofała ze sprzedaży na całym świecie, z wyjątkiem Japonii, lek obniżający poziom cholesterolu o nazwie Lipobay - poinformował PAP dział public relations firmy.

Powodem wycofania jest zwiększona liczba raportów o niepożądanych efektach zażywania leku - chodzi o osłabienie mięśni, głównie u pacjentów leczonych jednocześnie gemfibrozilem (w Polsce leki zarejestrowane pod nazwami: Afibrozil, Gemfibral, Gevilon, Lipozil, Lipur, Lopid).

W Japonii nie jest dostępny gemfibrozil, dlatego tam Bayer nie wycofał Lipobayu.

W ulotce dla pacjenta podawano informacje, że Lipobayu nie można stosować z podanymi wyżej lekami.

Doc. Lidia Chojnowska z Instytutu Kardiologii w Aninie radzi pacjentom, którzy zażywali łącznie dwa leki, by bez paniki zwrócili się do swoich lekarzy. "Lekarze powinni wykonać odpowiednie badania biochemiczne" - powiedziała. Według niej, łączenie dwóch leków występowało sporadycznie.

Firma oświadczyła, że w Polsce nie odnotowano żadnego przypadku niewłaściwego działania po stosowaniu leku.

Producent zapewnia, że ewentualne przywrócenie leku do sprzedaży zależeć będzie od oceny stosunku ryzyka do korzyści stosowania preparatu oraz od decyzji firmy i urzędów rejestrujących.

Rodzina mężczyzny z Oklahomy, który zmarł na powikłania nerek po braniu leku antycholesterolowego Baycol, pozwała do sądu jej amerykańskiego producenta, Bayer Corp., filię znanego niemieckiego koncernu Bayer.

O wniesieniu sprawy do sądu poinformował we wtorek adwokat rodziny zmarłego. Jest to pierwszy w USA przypadek procesu związanego z kuracją Baycolem (amerykańska nazwa Lipobay). Według wcześniejszych informacji amerykańskiego urzędu ds. żywności i leków (FDA) kuracji tej w Stanach Zjednoczonych przypisuje się 31 zgonów.

Niemiecki koncern Bayer wycofał w zeszłym tygodniu Baycol z rynku z powodu doniesień o potencjalnie śmiertelnych skutkach ubocznych preparatu, który wywołuje m.in. degenerację mięśni. Na całym świecie z lekiem tym wiąże się obecnie 52 zejścia śmiertelne.

Pozew w Oklahomie wniosła w zeszły piątek rodzina Liliberta Sparksa, który zmarł 2 marca z powodu niedrożności nerek wywołanej poważną degeneracją mięśni - wyjaśnił Don Strong z biura adwokackiego Strong, Martin & Associates.

Zdaniem mecenasa odszkodowanie w tym procesie może osiągnąć "wielomilionowy poziom".

Niemiecka firma Bayer AG, zagrożona kosztownymi pozwami o odszkodowania za skutki uboczne jednego ze swych leków, oświadczyła w poniedziałek, że jego szkodliwe działanie jest nieudowodnione, przeto pozwy są bezpodstawne.

Bayer, koncern chemiczny i farmaceutyczny, wycofał na początku sierpnia ze sprzedaży lek antycholesterolowy o nazwie Baycol (w USA znany jako Lipobay), bo pojawiły się doniesienia o jego potencjalnie groźnych skutkach ubocznych, takich jak degeneracja mięśni. Na całym świecie z lekiem tym łączy się obecnie 52 zgony.

Firma niemiecka stoi teraz wobec groźby kosztownych pozwów ze strony pacjentów. Zgłoszono je już co najmniej w czterech stanach USA i we Francji, a w Niemczech zainteresowanie wniesieniem skargi wyraziło podobno przeszło 100 osób.

Amerykański adwokat Ed Fagan, znany z udziału w wywalczeniu 10 miliardów marek odszkodowań dla robotników przymusowych Trzeciej Rzeszy, wystąpił w imieniu pewnego mieszkańca Nowego Jorku o potraktowanie jego wniosku o odszkodowanie jako pozwu zbiorowego. Niemiecki adwokat Michael Witti oświadczył w berlińskim InfoRadio, że łączna suma odszkodowań może wynieść "dobrych kilkaset milionów".

Bayer odrzuca te roszczenia jako "bezpodstawne". Przewodniczący zarządu firmy, Manfred Schneider, oświadczył w zeszłym tygodniu, że Bayer nie odkłada żadnych sum na ewentualne odszkodowania. W poniedziałek Bayer zdecydował się na niecodzienny krok i ogłosił swe stanowisko w formie całostronicowego ogłoszenia na łamach "Sueddeutsche Zeitung".

Schneider oświadcza w nim, że "nie ma obecnie żadnych dowodów na związek między stosowaniem preparatów obniżających poziom cholesterolu a śmiercią pacjentów".

"Zostaliśmy zaskoczeni rozwojem wydarzeń. Podczas dokładnego klinicznego procesu - zgodnego z ostrymi przepisami kompetentnych władz - aż do momentu dopuszczenia Cerivastatiny, będącej substancją czynną naszego leku Lipobay/Baycol, nie zauważyliśmy nic szczególnego, jeśli chodzi o skutki uboczne w postaci osłabienia mięśni".

Szef Bayera przypomina zarazem, że w ulotkach dołączanych do lekarstwa i w informacjach dla lekarzy firma ostrzegała od początku, iż Lipobay/Baycol stwarza ryzyko, jeśli zażywać go jednocześnie z innym preparatem, o nazwie Gemfibrozil.

Innym powodem komplikacji mogło być - zdaniem szefa koncernu - stosowanie maksymalnej dawki leku już na początku kuracji, choć Bayer zalecał stopniowe podwyższanie dawki.

Schneider podkreśla, że Bayer zdecydował się na wycofanie leku, bo nie można było wykluczyć, że lekarze będą nadal stosować dotychczasowe praktyki.

Firma postanowiła "dobrowolnie" wycofać lek z rynku, choć wie, iż będzie to miało daleko idące konsekwencje dla przedsiębiorstwa - dodaje szef koncernu niemieckiego, mając na myśli głównie utratę wpływów ze sprzedaży Lipobay/Baycolu.

Stamford, CT (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Cracovia Company LLC, is recalling E. Wedel Brand Chocolate Covered Gingerbread Cookies with Strawberry Filling because the product contains the unapproved color additive Ponceau 4R.

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

PRODUCT:
E. Wedel Brand Chocolate Covered Gingerbread Cookies with Strawberry Filling

Recall Number:
F-490-1

CODE: 7.93 oz. (225 gm) and 5.29 oz. (150 gm) Product is in a plastic bag with printed label in various languages reading in part, "E. Wedel Pierniczki ALPEJSKIE NADZIENIE TRUSKAWKOWE***"

REASON:
The product contains the unapproved color additive Ponceau 4R.

MANUFACTURER:
Danone Clastka Sp. z o. o., (Polska) Poland

RECALLED BY:
Cracovia Company LLC, Stamford, CT, NWE-DO visited firm in response to NY sample results revealing the unpermitted color Ponceau 4R.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
6 New England States, NJ and NY

QUANTITY:
310 cases

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

Minneapolis, MN (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Hawkins Chemical, Inc. is recalling Chloroquine Phosphate Bulk Powder because bottles labeled to contain Chloroquine Phosphate Powder were found to contain Clonodine.

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

PRODUCT:
Chloroquine Phosphate Bulk Powder, for compounding, in bottles labeled as containing 5, 25, 100, or 500 grams per bottle. The bottles are also labeled as packaged by Universal Chemical, St. Peter, MN.

RECALL NUMBER:
D-281-1.

Code: Lot UC99020502, Packaged 02/99, CAS 50-63-5

REASON:
Mix-up; bottles labeled to contain Chloroquine Phosphate Powder were found to contain Clonodine, an Anti-hypertensive drug.

MANUFACTURER/RECALLING FIRM:
China North Industries Nanjing Corporation, Nanjing, China,

RECALLED BY:
Hawkins Chemical, Inc., Minneapolis, MN, sent Recall letters dated 1/24/01 and 1/25/01 to the direct account and sub-account that received the 5-gram bottles of the drug.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
AZ, CA, FL, LA, MN, OR, SC, TN, UT

QUANTITY:
The following numbers of bottles of chloroquine phosphate, having lot number UC99020502, were shipped: four 5-gram bottles; twenty 25-gram bottles; twenty 100-gram bottles; and five 500-gram bottles.

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

Holland, MI (SafetyAlerts) - Bareman Dairy today announced that, in cooperation with the U.S. Food and Drug Administration (FDA), it is conducting a recall of 19,700 Gallons of Bareman Dairy Crystal Clear Drinking Water Packaged in One Gallon Containers. The Gallon Containers are coded will a “sell by” date of Dec 8 JD.

Bareman Dairy has determined that a portion of this lot may contain a equipment sanitizer. This sanitizer is made of a mix of peroxiacetic acid and hydrogen peroxide. Consumption may cause irritation or burning of the throat and stomach. If you experience irritation or burning, immediately dilute by drinking several glasses of water and contact the proper medical authority, do not induce vomiting.

The recall is being instituted after company testing pursuant to a customer complaint received at 10:00AM Thursday August 16, 2001.

The product, run under the Bareman Dairy label, is distributed in Michigan’s Lower Peninsula, Northwestern Indiana, and Illinois.

Consumers who purchased the Drinking Water dated December 8 are urged to discontinue use of the product immediately and return to the place of purchase for a full refund.

Any questions contact Bareman Dairy at 1-800-968-6600.

San Antonio, Texas (SafetyAlerts) - Villarreal Distributors of San Antonio, Texas, is recalling over 20,000 candy containing clay pots of JARRITOS brand Tamarindo candy because the candy has been found to contain excessive levels of lead. Lead is very toxic and dangerous to humans, especially children, women of childbearing age, pregnant women and their unborn children. Although people with lead in their blood often do not exhibit the symptoms of lead toxicity, such symptoms include the following: stomach aches, colic, nausea, vomiting, abnormal irritability, and insomnia. Lead can also permanently damage the central nervous system, resulting in learning difficulties in school children as well as cause other long-term health problems.

The JARRITOS brand Tamarindo candy was distributed in IL, OH, WI, NJ, MI, IA, MO, MN, IN, TN, KY, NE, SC, AL and MD, through retail sites, especially ethnic markets, stores and bakeries that cater to Latinos. The product is imported from Mexico, manufactured by La Barca II Dulceria in Jalisco, Mexico.

The product is sold as 12 candy containing clay pots per labeled package. The label says JARRITOS and Tamarindo 100% Natural with a picture of a boy. Each pot is also individually packaged in an unlabeled clear plastic bag and some retail sites may sell the pots individually. Each pot contains approximately 30 grams of the candy.

No illnesses have been reported to date.

The recall was the result of a routine sampling program by the Food and Drug Administration that revealed that the candy had levels as high as 4.60 ppm. It is believed the lead has leached from the clay pots into the candy.

Consumers are urged not to consume the product and return any product in their possession to the place of purchase. Consumers with questions should contact Villarreal Distributors at (210) 224-9720.

Eden Prairie, MN (SafetyAlerts) - XL Machine Ltd. is voluntarily recalling about 10,000 sets of dollhouse bathroom furniture. The yellow paint on the furniture contains lead, which can present a risk of lead poisoning to young children.

CPSC and XL Machine Ltd. have not received reports of any injuries relating to these dollhouse furniture sets. This recall is being conducted to prevent the possibility of injury.

The Little Tree natural wood dollhouse bathroom furniture sets contain a tub, sink with mirror, toilet, shower, bench, towel rack and a wooden doll. The doll has hair made of yarn and bendable wire legs and arms. The fixtures on the bathroom furniture are painted yellow. The packaging for the set reads "Little Tree," "Distributed by Target Corporation," and "MADE IN CHINA."

Target stores nationwide sold these furniture sets from August 2000 through June 2001 for about $15.

Consumers should immediately take these dollhouse furniture sets away from children, and return the sets to the Target store where purchased for a refund. For more information, call XL Machine Ltd. at (866) 746-8097 between 9 a.m. and 5 p.m. CT Monday through Friday.

Notice of this product warning was sent via email to SafetyAlerts subscribers August 20, 2001.  For more information regarding the SafetyAlerts free email alert service