Generic Tylenol
Stripes
14/11/2006

My family has always bought generic tylenol...either WalMart brand or Dollar General usually. Anyway this worries me since I"ve recently taken some...

MILLIONS OF ACETAMINOPHEN PILLS RECALLED
Metal fragments found in generic 500-milligram caplets, maker says
Pasted from http://www.msnbc.msn.com/id/15636847/


ASSOCIATED PRESS
Updated: 11:13 a.m. CT Nov 10, 2006
WASHINGTON - Check your medicine cabinet: Millions of bottles of the widely used pain reliever acetaminophen � some sold as long as three years ago � are being recalled because they may contain metal fragments.
The recall affects 11 million bottles containing varying quantities of 500-milligram acetaminophen caplets made by the Perrigo Co. The pills were sold under store brands by Wal-Mart, CVS, Safeway and more than 120 other major retailers, the Food and Drug Administration said. At least one chain started pulling the pills from store shelves Thursday.
There were no immediate reports of injuries or illness. The contaminated pills included metal fragments ranging in size from �microdots� to portions of wire one-third of an inch long, the FDA said. The FDA could not describe further the type of metal.
Perrigo discovered the metal bits during quality-control checks done after the company discovered its equipment was wearing down prematurely, the FDA said. Agency officials declined to say whether the metal found in the pills caused the damage or resulted from it.
A company investigation turned up metal in roughly 200 pills of the 70 million it passed through a metal detector, according to the FDA.
Consumers who take any of the contaminated pills could suffer minor stomach discomfort or possible cuts to the mouth and throat, the FDA said, adding that the risk of serious injury was remote. Anyone who suspects they have been injured should contact a doctor.
Acetaminophen is best known as the drug in products sold under the Tylenol brand, but is widely available in typically less expensive generic versions. The drug, along with aspirin and ibuprofen, is one of the most widely used pain relievers available without a doctor�s note.
The retail market for the pain-relievers is worth more than $2 billion a year, according to Perrigo, which bills itself as the world�s largest manufacturer of store-brand nonprescription drugs.
Kevin Vincent, 44, of Arlington, Va., said his wife buys store brand acetaminophen and he wanted to find out more about the problem. �If it�s not something that has any chance of recurring, then I really wouldn�t worry,� he said. The 129 retailers that could potentially be affected by the recall include Wal-Mart Stores Inc., CVS Corp., Safeway Stores and SuperValu Inc. They typically sell the Perrigo-made pills under their own or other private labels.
CVS will stop selling its own brand of 500-milligram acetaminophen caplets and pull bottles from store shelves nationwide, spokesman Mike DeAngelis said. Messages left with the other chains were not immediately returned.
Perrigo, based in Allegan, Mich., said the pills contained raw material purchased from a third-party supplier and affected 383 batches. Messages left with two company spokesmen were not immediately returned.
The FDA declined to identify the source of the raw materials. However, the agency doesn�t suspect the contamination was deliberate, said Dr. Douglas Throckmorton, deputy director of the FDA�s Center for Drug Evaluation and Research.
Molly Walsh, 21, a George Washington University student shopping at a CVS pharmacy in Washington, D.C., said she didn�t plan to toss any of the store-brand drugs at home that she�d bought to save money. Nor did she plan to stop buying the generic products.
�It�s still going to be cheaper and I�m still going to be broke after the recall,� Walsh said.
The recall does not affect Tylenol. Nor should the recall cause a shortage of acetaminophen, the FDA said.
The voluntary recall is considered a Class II recall since it covers products that might cause a temporary health problem or pose only a slight threat of a serious nature, the FDA said.
Consumers with questions can call Perrigo toll free at (877) 546-0454.
The FDA would not say in which states the pills had been sold, but instead recommended that customers determine whether products they bought are being recalled by checking the store list on the FDA Web site.
The batch numbers appear on the container�s label.
It wasn�t immediately clear where Perrigo made the pills. Its main factories are in the United States and Israel, with secondary plants in the United Kingdom, Mexico, Germany and China.
Perrigo has carried out at least 32 other product recalls since 1993, according to FDA records. As recently as May, it recalled nearly 59,000 bottles of a 500-milligram combination pain-reliever and sleep aid that contains acetaminophen because of contamination with acrylic mirror particles.
A major manufacturer of acetaminophen sold by Wal-Mart, CVS, Safeway and more than 100 other retailers recalled 11 million bottles of the widely used pain-relieving pills Thursday after discovering some were contaminated with metal fragments.
There were no immediate reports of injuries or illness. The recall affects bottles containing various amounts of 500-milligram caplets made by the Perrigo Co.
The contaminated pills included metal fragments ranging in size from �microdots� to portions of wire one-third of an inch long, the Food and Drug Administration said. Perrigo discovered the metal bits during quality-control checks after realizing the equipment it uses to make pills was wearing down prematurely, the FDA said.
A company investigation turned up metal in roughly 200 pills, after passing 70 million of the caplets through a metal detector, according to the FDA.
Consumers who swallow any of the contaminated pills could suffer minor stomach discomfort or possible cuts to the mouth and throat, the FDA said, adding that the risk of serious injury was remote. Anyone who suspects they have been injured should contact a doctor, the agency said.
The FDA posted on its Web site the recalled batch numbers and the dozens of chains supplied by Perrigo, which bills itself as the world�s largest manufacturer of store-brand nonprescription drugs. The 129 retailers that could potentially be affected by the recall include Wal-Mart Stores Inc., CVS Corp., Safeway Stores and SuperValu Inc. They typically sell the Perrigo-made pills under private labels.


STORES POSSIBLY AFFECTED BY PILL RECALL
Generic drug maker found metal fragments in caplets
Pasted from http://www.msnbc.msn.com/id/15637699/

MSNBC
Updated: 10:39 a.m. CT Nov 9, 2006
The U.S. Food and Drug Administration has announced a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Mich. for 383 batches of acetaminophen 500-milligram caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets.

A.B. Wholesale
Access Business Group
Albertsons
Allied Merchandising Ind.
AMCON Distributing
AMCON Distributing Co.
American Sales Co.
AMERISOURCE-BERGEN
Anda Inc.
Anderson Wholesale
Bacon Grocery
Bellco Drug Corp
Bell's Wholesale
BJ's Wholesale
Brenham Wholesale Groc.
BROOKS ECKERD DRUG
Brookshire Brothers, Ltd
Urklund Distr. Inc. (GOODSENSE)
C & S Wholesale
Caldwell Wholesale
Capital Candy
Cardinal
Caridnal Health, Inc.
City Supplies
Con-Jel Sales Corp.
Crest Discount Food (GOODSENSE)
Crossroads Sales
Cumberland Swan
CVS
Dakota Drug
Dearborn Wholesalers
Dik Drug
Discount Distributors
Discount Drug Mart
Dohman Dist Partner Central
DOLLAR GENERAL CORP.
DOUGLAS COMPANIES, Inc.
DUCKWALL-ALCO WHSE
ECKERD DRUG COMPANY
F.Dohmen
FARNER-BOCKEN Co.
FLEMING CSD - PLYMOUTH DIVISION
Foley's Inc.
Food Lion
Frank Kerr
Fred Meyer
Geiss, Destin, Dunn
Gem State Distributors
General Merchandising
GENERIX
GREAT LAKES WHOLESALE
GREAT NORTH FOODS
Grocers Supply
GROCERY SUPPLY CO.-SULPHUR SPG
H. MORGAN CORPORATION
H.E. BUTT
H.T. Hackney
HACKNEY SERVICE MDSERS, INC.
HANNAFORD PROGRESSIVE
HARBOR WHOLESALE GROCERY CO.
HD Smith Wholesale
HERMAN DISTRIBUTORS INC.
Hy-Vee
IMPERIAL TRADING COMPANY, INC.
INTERNATIONAL AID ITEMS GALORE, INC.
Keefe Supply
KING DRUG COMPANY
KMART RESOURCE CENTER
Kroger
Kwik Trip, Inc
Lani LLC
Long's D&K (Hawaii)
Long's Drug Stores
LONG'S HAWAII
M.R. WILLIAMS, INC.
McKesson
McQueary Brothers Wholesale
MDI, INC.
Meijer
Melaleuca/ B&V
MERCHANDISE INC
MEYERS SUPPLY INC.
MIAMI-LUKEN, INC.
Millbrook Dist
Mills Fleet Wholesale Supply
MORALES DISTRIBUTORS
Morris & Dickson
National Wholesale Liq.
PathMark Stores, Inc.
PECHIN MARKET
PIGGLY WIGGLY
PRESCRIPTION SUPPLY, INC.
PROGRESSIVE DISTRIB - Disc
Promotions Unlimited
PUBLIX SUPER MARKETS INC.
QUEST PHARMACEUTICALS, INC.
RALEY'S SUPERMARKETS
Ralph's Grocery
RALPH'S PEARL ST.
ROUNDY'S (GOOD SENSE)
ROUNDY'S, INC.
SAFEWAY STORES
Sav-A-Lot
SAVE MART SUPERMARKETS
SERV A RACK INC
Smith Wholesale Drug
SOMODY SUPPLY INC.
SOUTHCO DISTR CO
ST. JOSEPH DISTRIBUTING
STEPHENSON WHLSE (GOODSENSE)
Stewarts Shop Corp.
Super Valu
SUPER VALU, Inc.
SuperMarket Services
THOMAS & HOWARD COMPANY
THOMPSONS EMPORIUM
Topco
VARIETY DISTRIBUTORS
VARIETY WHOLESALERS, INC.
W. LEE FLOWERS COMPANY
Wakefern ShopRite
Wal-mart
WALSH HEARTLAND, L.L.C.
WALSH SOUTHWEST, L.L.C.
WILLIAM MACGILL
WINCO FOODS
WINN DIXIE STORES, Inc.
WOODMAN'S FOOD MARKET, Inc.

Now since I'm on a role of posting anything useful about this...here's what the FDA says:

FDA News
FOR IMMEDIATE RELEASE
P06-183
November 9, 2006
Media Inquiries: 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets
The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Approximately 11 million bottles containing varying quantities of acetaminophen 500mg caplets are affected by this recall. For a list of batches affected, please see www.fda.gov/oc/po/firmrecalls/perrigo/perrigobatchlist.html. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall is located on FDA's website at www.fda.gov/oc/po/firmrecalls/perrigo/perrigocustlist.html.

To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they've been harmed by use of this product.

Consumers who believe they are in possession of the affected products should discontinue use immediately and call Perrigo's Consumer Affairs Department, 877-546-0454 for further instructions. Any adverse reactions experienced with the use of this product should be reported to Perrigo at the above number and the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178 or on the MedWatch website at www.fda.gov/medwatch.

FDA is currently investigating the cause of the metal particles found in the acetaminophen 500 mg. caplets. Perrigo originally informed FDA of this problem after discovering through their own regulatory quality control procedures that their tableting equipment was wearing down prematurely. The company is also investigating the cause of the problem. The ongoing investigations have revealed the presence of the metal fragments in caplets of acetaminophen, 500 mg. Perrigo reported to the FDA that 70 million caplets were passed through a metal detector; resulting in the discovery of approximately 200 caplets containing metal fragments ranging in size from "microdots" to portions of wire 8 mm in length.

At this time FDA does not anticipate that this action will cause a shortage of acetaminophen. Currently, only one strength (500 mg caplets) is affected. Consumers may wish to take additional amounts of the lower strengths of acetaminophen tablets or caplets, which are not affected by this recall, to reach the 500 mg dose or access acetaminophen produced by alternate manufacturers. In all instances, FDA advises consumers to follow labeled instructions for maximum daily dosage.

Perrigo is notifying its distributors and retailers of this issue and will inform them of steps it will take to facilitate product replacement.


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