Johnny_Blaze_47
11-09-2006, 12:28 PM
Heads-up.
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11M bottles of acetaminophen recalled
By ANDREW BRIDGES
Associated Press Writer
WASHINGTON (AP) -- 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.
Perrigo, based in Allegan, Mich., said the pills contained raw material purchased from a third-party supplier and affected 383 batches. A company spokesman did not immediately return a call seeking comment.
Acetaminophen is best known as the drug in products sold under the Tylenol brand, but is widely available in 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.
The recall does not affect Tylenol. The recall should not 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, according to the FDA.
Consumers with questions can call Perrigo toll free at (877) 546-0454.
Customers can check whether products they bought are being recalled by checking the store list on the FDA Web site.
http://hosted.ap.org/dynamic/stories/D/DRUG_WARNING?SITE=TXSAE&SECTION=US&TEMPLATE=DEFAULT
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http://www.fda.gov/bbs/topics/NEWS/2006/NEW01507.html
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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11M bottles of acetaminophen recalled
By ANDREW BRIDGES
Associated Press Writer
WASHINGTON (AP) -- 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.
Perrigo, based in Allegan, Mich., said the pills contained raw material purchased from a third-party supplier and affected 383 batches. A company spokesman did not immediately return a call seeking comment.
Acetaminophen is best known as the drug in products sold under the Tylenol brand, but is widely available in 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.
The recall does not affect Tylenol. The recall should not 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, according to the FDA.
Consumers with questions can call Perrigo toll free at (877) 546-0454.
Customers can check whether products they bought are being recalled by checking the store list on the FDA Web site.
http://hosted.ap.org/dynamic/stories/D/DRUG_WARNING?SITE=TXSAE&SECTION=US&TEMPLATE=DEFAULT
---------------
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01507.html
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.