Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

Biomedic Ultra Headache Relief (November 30, 2012)

Starting date:
November 30, 2012
Posting date:
December 24, 2012
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-26131

Reason

Error in labelling. The English side panel is missing the ingredient name 'Caffeine' whereby the labeling incorrectly states "Each tablet contains: Acetaminophen 500mg and 65mg" (the word Caffeine is missing). The French side panel correctly states the two ingredients. Caffeine is correctly stated in the front panel (both in English and French).

Depth of distribution

Total of 5055 Units of Finished Goods were shipped to the following wholesalers and retailers: Familiprix, Unipharm Wholesale Drugs Ltd, Kohl and Frisch Ltd, and Value Drug Mart (all located in Quebec)

Affected products

Biomedic Ultra Headache Relief

DIN, NPN, DIN-HIM

DIN 02264870

Dosage form

Tablet

Strength

  • Acetaminophen 500 mg
  • Caffeine 65 mg

Lot or serial number

0J10927QU, 1E2102F8S, 2D1042RLG

Companies

Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg MB Manitoba
Canada R2J 3W2
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg MB Manitoba
Canada R2J 3W2