Example: [Collected via e-mail, 2006]
I received the following info and wanted to verify its accuracy through your site.
A major U.S. manufacturer of store-brand acetaminophen has recalled
There were no immediate reports of injuries or illness.
Perrigo Co. said it discovered the metal bits during quality-control checks.
The recall affects bottles containing various amounts of
Perrigo bills itself as the world's largest manufacturer of store-brand nonprescription drugs. The company did not disclose the chains for which it manufactures the store-brand acetaminophen.
However, Wal-Mart Stores Inc., CVS Corp., Walgreen Co. and Costco Wholesale Corp. are among the companies it supplies with health care products, according to company Securities and Exchange Commission filings.
It was not immediately known if Perrigo has international customers.
The name-brand version of acetaminophen is Tylenol, and generic acetaminophen is often found on store shelves right next to Tylenol products. However, the recall does not affect Tylenol, and it should not cause a shortage of acetaminophen, the FDA said.
Perrigo said the pills contained raw material purchased from a third-party supplier and affected
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 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 their doctor, the agency said.
The FDA said Perrigo began investigating after realizing the equipment it uses to make pills was wearing down prematurely.
According to the FDA alert about the Perrigo acetaminophen recall:
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
At this time FDA does not anticipate that this action will cause a shortage of acetaminophen. Currently, only one strength
Perrigo is notifying its distributors and retailers of this issue and will inform them of steps it will take to facilitate product replacement.
The FDA's web site also offers consumers a list of stores where products covered by this recall might be offered for sale.
|FDA Informs Public of Nationwide Recall of 500mg Strength
Store-Brand Acetaminophen Caplets (FDA)
|Recalled Batches of Acetaminophen 500mg
Pain Reliever Caplets (FDA)
Bridges, Andrew. "Massive Recall of Acetaminophen Under Way." Houston Chronicle. 9 November 2006.