I am a pharmacist in consulting practice.
Yes this is a real problem and if you have within the past several months purchased caplets of generic Tylenol (known as acetaminophen) I would put it aside and purchace a 30 day supply of BRAND NAME PRODUCT (made by McNeil) Tylonol. This probelm could effect generic acetamionphen from many different stores. There were and estimated 11 Millon bottles of product involved. Part of the issue here is the overall quality and reliability of any generic product.
Attached for your reference is a copy of an ALERT issued by the American Pharmacist Association in Washington DC to its membership on this problem:
"Metal fragments result in large acetaminophen recall
Perrigo, supplier of store brands to dozens of retailers, says metal fragments might be in caplets of 11 million bottles; FDA investigating.
A recall announced this morning by FDA affects some 11 million bottles of store-brand acetaminophen distributed nationally, including many large retailers such as Eckerd, Fred Meyer, Kroger, Long’s Drug Stores, McKesson, Publix, Ralph’s, Safeway, and Wal-Mart. Conducted by Perrigo Company of Allegan, Mich., the recall affects 383 lots of acetaminophen 500 mg caplets and resulted from presence of small metal fragments found in a few of these caplets.
To date, no illness or injuries related to this problem have been reported, and no consumers have complained to FDA or Perrigo. Based on information currently available, FDA believes the probability of serious adverse health consequences is remote; if a consumer were to swallow a caplet containing metal fragments, it could cause 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 (see links below for lot numbers and store brands) should discontinue use immediately and call Perrigo’s Consumer Affairs Department at 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 Web site
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 tablet-making 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 these caplets. Perrigo reported to the FDA that 70 million caplets were passed through a metal detector, and this resulted 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 use acetaminophen produced by other 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."
2006-11-10 01:25:07
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answer #1
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answered by Anonymous
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The recall affects 11 million bottles containing varying quantities of 500-milligram acetaminophen caplets made by the Perrigo Co. for more than 120 national retailers, including Wal-Mart, Sears, Kmart and CVS Corp.
Perrigo-made acetaminophen is also carried by local grocers Dominick's, which carries it under the Safeway brand, and Jewel, which carries it under the Equaline name. Both grocers were offering refunds on affected lots.
Ouch!
2006-11-09 19:16:56
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answer #2
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answered by San Diego Art Nut 6
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YES, it is all over the tv, news, etc.
Don't buy generic although they are usually perfect strength because by federal standards, the compounds have to be pretty much the same, just a few items got through, so they recalled them all.
If you grandmother has a headache, find out whether it is from allergies, sight, new glasses, stress or a sinus cold, they all have a little something different according to the headache Sousa.
If her headache gets worse and you notice any unusual stuff happening recently accompanying the headaches, I strongly recommend that you take her to her doctor.
:Let me know how else I can help you.
Susie
2006-11-09 19:21:35
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answer #3
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answered by wildmedicsue 4
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This is what cnn says
WASHINGTON (AP) -- 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 two chains -- CVS Corp. and SuperValu Inc. -- 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 noticed that 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, Virginia, 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. SuperValu also began removing the pills from its Albertsons, Cub Foods and other stores, spokeswoman Haley Meyer said. Messages left Thursday with the other chains were not immediately returned.
Perrigo, based in Allegan, Michigan, 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 did not know 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 listexternal link on the FDA Web site and the batch listexternal link.
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.
2006-11-09 19:16:11
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answer #4
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answered by ebaijunky06 3
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One of the tableting machines had metal flaking off of it.
This event does not mean stop taking generics. Generics are bioequivalent, that means through testing, the generic product has proven to act the same as the brand name.
2006-11-10 00:39:09
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answer #5
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answered by Lea 7
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From what I read the recall involved acetominaphen-containing products--except Tylenol. You're safe. You option is to return the new bottle.
2006-11-09 19:19:02
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answer #6
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answered by Anonymous
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State of California has already been declared a state of emergency for prevention. and that they are speaking approximately ultimate greater colleges. we can see what occurs. Its consistently something even with the undeniable fact that.. i can not say i'm scared through fact that is existence. If the swine flu would not get us, the earthquakes will.
2016-11-23 13:51:29
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answer #7
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answered by Anonymous
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Yes, just heard. this was a generic distributor , and not name-brand acetaminophen like Tylenol.
Buy the name brands for now, or consider aspirin or naproxen as substitutes.
2006-11-09 19:15:03
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answer #8
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answered by jont 2
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http://news.yahoo.com/s/ap/20061109/ap_on_he_me/drug_warning
2006-11-09 19:21:20
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answer #9
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answered by Anonymous
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