Advisory

2006-109
November 11, 2006
For immediate release

Acetaminophen Recall in the United States

OTTAWA -Health Canada is advising Canadians of the recall of 11 million bottles of store brand pain-relieving pills in the United States due to contamination with metal fragments.

Health Canada has received confirmation from the company that the affected bottles have not been distributed to Canada, but the product may have been purchased by travellers or over the Internet.

The affected bottles contain various amounts of 500 milligram caplets manufactured by Perrigo Company of Allegan, Michigan. The manufacturer discovered the metal fragments during its quality control process. The recall is to the retail level, so retailers are instructed to remove the product from shelves.

Consumers can determine if they have purchased a bottle of the recalled product by locating the batch number printed on the container's label. For a list of the batches affected, please consult the list provided on the Food and Drug Administration's (FDA) Web site. The site also has a list of the stores in the United States that carry store-brands potentially affected by the recall.

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.

To date, there have been no reports of illness or injuries related to this problem and no consumer complaints have been received by the FDA in the United States or by the manufacturer.

Consumers who believe they have the affected product should immediately discontinue its use and should consult their physician if they suspect they have been harmed by it. Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

To report a suspected adverse reaction with this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
email: cadrmp@hc-sc.gc.ca

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709