READ: Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets

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~http://www.fda.gov/bbs/topics/NEWS/2006/NEW01507.html

FOR IMMEDIATE RELEASE

P06-183

November 9, 2006

Media Inquiries:

Consumer Inquiries:

888-INFO-FDA

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,

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.

Angie, the plant lady