Berkeley CSUA MOTD:Entry 45307
Berkeley CSUA MOTD
2019/04/20 [General] UID:1000 Activity:popular

2006/11/9-10 [Health/Dental, Health] UID:45307 Activity:nil
11/9    FDA announces recall of some store-brand acetaminophen:
        List of stores that might be affected:
2019/04/20 [General] UID:1000 Activity:popular

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Manuel Balce Ceneta / AP A major manufacturer of acetaminophen sold by Wal-Mart, CVS, Safeway and more than 100 other retailers found metal fragments in caplets during quality-control checks. 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. The contaminated pills included metal fragments ranging in size from "microdots" to portions of wire one-third of an inch long, the FDA said. 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. "If it's not something that has any chance of recurring, then I really wouldn't worry," he said. They typically sell the Perrigo-made pills under their own or other private labels. Bottles pulled nationwide 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. 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. List of stores possibly affected by recall Molly Walsh, 21, a George Washington University student shopping at a CVS pharmacy in Washington, DC, said she didn't plan to toss any of the store-brand drugs at home that she'd bought to save money. "It's still going to be cheaper and I'm still going to be broke after the recall," Walsh said. 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.
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Those caplets are over-the-counter drugs for pain relief and fever reduction. They're sold by about 130 companies, including Wal-Mart, CVS, and other drug stores, grocery stores, and wholesalers. The recall is due to "small metal fragments found in a small number of these caplets," states an FDA news release. The fragments range in size from "microdots" to 8-millimeter pieces of wire, according to the FDA. So far, no illnesses, injuries, or consumer complaints have been reported to the FDA or Perrigo, according to the FDA. The FDA "believes the probability of serious adverse health consequences is remote," the FDA's Jason Brodsky told reporters in a teleconference. Brodsky is the FDA's assistant commissioner for external relations. "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," Brodsky says. The FDA's web site also lists the recalled batches of the drug. The recalled drugs have expiration dates ranging from September 2006 through August 2009. The FDA advises consumers who believe they have the recalled acetaminophen to "discontinue use immediately" and call Perrigo's consumer affairs department at (877) 546-0454 for further instructions. People who think they may have been harmed by the affected caplets should talk to their doctors, says Brodsky. "We believe, at present, that this is a relatively small fraction of the total available acetaminophen on the market," the FDA's Douglas Throckmorton, MD, told reporters in the teleconference. Throckmorton is the deputy director of the FDA's Center for Drug Evaluation and Research. Adverse reactions should also be reported by phone to Perrigo's consumer affairs department at (877) 546-0454, says the FDA. Investigation Under Way According to the FDA, Perrigo told the FDA about the problem on Nov. The FDA says Perrigo told the FDA that 70 million caplets went through a metal detector, resulting in the discovery of about 200 caplets containing metal fragments ranging from "microdots" to portions of wire 8 millimeters long. Perrigo is working with the FDA on correcting the problem. In a Perrigo news release, the company says it bought raw materials for the caplets from a third-party supplier. John Hendrickson, Perrigo's executive vice president and general manager of Perrigo Consumer Health Care, commented on the recall in Perrigo's news release. "Our quality control systems noted trace amounts of metal particulate in a very small number of these caplet products," Hendrickson says. "Although the frequency of occurrence is very low, the probability of health risk is remote, and there have been no reports of injuries or illness related to this incident, we are taking this measure to maintain the highest possible product quality standards for our retail customers and their store brand consumers." Jason Brodsky, assistant commissioner for external relations, FDA. Douglas Throckmorton, MD, deputy director, Center for Drug Evaluation and Research, FDA.
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More Health News Stores possibly affected by pill recall Generic drug maker found metal fragments in caplets MSNBC The US 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. AB Wholesale Access Business Group Albertsons Allied Merchandising Ind. Anderson Wholesale Bacon Grocery Bellco Drug Corp Bell's Wholesale BJ's Wholesale Brenham Wholesale Groc. BROOKS ECKERD DRUG Brookshire Brothers, Ltd Urklund Distr. 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. DUCKWALL-ALCO WHSE ECKERD DRUG COMPANY FDohmen FARNER-BOCKEN Co. 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 MR WILLIAMS, INC. Meijer Melaleuca/ B&V MERCHANDISE INC MEYERS SUPPLY INC. Millbrook Dist Mills Fleet Wholesale Supply MORALES DISTRIBUTORS Morris & Dickson National Wholesale Liq. PROGRESSIVE DISTRIB - Disc Promotions Unlimited PUBLIX SUPER MARKETS INC. SAFEWAY STORES Sav-A-Lot SAVE MART SUPERMARKETS SERV A RACK INC Smith Wholesale Drug SOMODY SUPPLY INC. JOSEPH DISTRIBUTING STEPHENSON WHLSE (GOODSENSE) Stewarts Shop Corp. SuperMarket Services THOMAS & HOWARD COMPANY THOMPSONS EMPORIUM Topco VARIETY DISTRIBUTORS VARIETY WHOLESALERS, INC. W LEE FLOWERS COMPANY Wakefern ShopRite Wal-mart WALSH HEARTLAND, LLC WALSH SOUTHWEST, LLC WILLIAM MACGILL WINCO FOODS WINN DIXIE STORES, Inc.