FDA Recall-11 million bottles of Acetaminophen Caplets 500mg

November 9, 2006
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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/p ... hlist.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/p ... tlist.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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A.B. WHOLESALE
ACCESS BUSINESS GROUP
Albertsons
ALLIED MERCHANDISING IND.
AMCON DISTRIBUTING
AMCON DISTRIBUTING COMPANY
AMERICAN SALES COMPANY
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.
BURKLUND DISTR.INC.(GOODSENSE)
C & S WHOLESALE
Caldwell Wholesale
CAPITAL CANDY
CARDINAL
CARDINAL 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
DOHMEN 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.

FYI for the Canadians: I heard on the radio that none of these tablets were distributed to Canada.

Thanks for posting that, Ron!