Warning
2001-92
August 18, 2001
Warning against using Pharma Choice Acetaminophen with Caffeine and Codeine Caplets, lot number 1C484
OTTAWA - 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 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 the 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.
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Media inquiries:
Dr. Brian Gillespie
Health Canada
(613) 941-3070
Micheline Ho
Health Canada
(613) 954-4922
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