NOTE: The warning below, issued by Health Canada, may be of interest to some U.S. citizens.

FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Warning Against Using Pharma Choice Acetaminophen with Caffeine and Codeine Caplets, Lot Number lC484

WARNING



Contact:   Micheline Ho
          (613) 954-4922
		  
		  Dr. Brian Gillespie (Media Inquiries)
		  (613) 760-3178 (pager)

For Immediate Release

OTTAWA - August 17, 2001- The Therapeutic Products Directorate of Health Canada is warning consumers in Ontario and Quebec not to use Pharma Choice Acetaminophen with Caffeine and Codeine Caplets, lot number 1C484. The products were found to contain ASA (acetylsalicylic acid) with Caffeine and Codeine, which for some people could cause severe, possibly fatal, adverse reactions.

This product should not be used if you: (1) are on anticoagulant therapy or have a bleeding disorder because it could result in serious bleeding; (2) suffer from stomach ulcers because it could cause serious complications; (3) are allergic to ASA because it could cause a severe allergic reaction; (4) are an asthmatic sensitive to ASA because it could result in a serious asthma attack; (5) are pregnant because it could cause problems/complications; or (6) a child or adolescent suffering from chicken pox because it could cause a serious adverse reaction.

The product, manufactured by Vita Health Products Inc., of Winnipeg and distributed by Medis Health and Pharmaceutical Services Inc., of Saint-Laurent, Quebec, is packed in white, oblong bottles with the words "Pharma Choice" printed across the label. The bottles from lot number 1C484 can be identified by their contents, which are in the form of round tablets, rather than long oval caplets as indicated on the label. The product was distributed in Quebec and Ontario.

Health Canada advises people who suffer from the above conditions and have taken this product recently to consult their physician/health care professional.

A recall has been voluntarily initiated by the manufacturer. However, 45 bottles of this product are unaccounted for, having been sold to consumers. There have been no reports of illness.

Health Canada continues to monitor the effectiveness of the recall.

FDA/Website Management Staff
Web page created by tg 2001-AUG-20.