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Public advisory

Archived – Health Canada advises about missing dosage information on the veterinary drug product PENPRO

Starting date:
September 26, 2006
Posting date:
September 26, 2006
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging, Product Safety
Audience:
General Public
Identification number:
RA-110001509

Health Canada is advising animal owners that some bottles of the veterinary drug PENPRO, an injectable penicillin used to treat bacterial infections in cattle, sheep, swine and horses, may have been sold without the package insert which provides the proper administration and dosage information. Without this information, the drug may be used inappropriately, which could result in adverse drug reactions for animals.

Since PENPRO is not a prescription drug, it may be used without veterinary consultation. Incorrect use could result in allergic reaction or pain and irritation at the injection site.

Consumption of meat and milk products from animals treated incorrectly with this drug is unlikely to result in serious adverse health effects in humans. While trace amounts of penicillin residues may potentially pose the risk of allergic reaction in susceptible individuals, the risk of a significant human health effect is remote.

The Canadian manufacturer of the drug, Vétoquinol N.-A. Inc., has acted to correct the problem. An instruction leaflet has been attached to each new bottle of PENPRO and a letter has been sent to retailers to inform them that some units of the product were distributed to end-users without the package insert. Retailers are also urged to make certain that an instruction leaflet accompanies each bottle in stock. It is possible, however, that some bottles have already been sold or remain on store shelves without the necessary instructions.

If you have purchased this product in a bottle without dosage information, it should be immediately returned to the place of purchase.

Consumers requiring more information about this advisory can contact the Health Canada public inquiries line at 613-957-2991, or toll free at 1-866-225-0709.
 

Media enquiries

Paul Duchesne
Health Canada
613-954-4807

Public enquiries

613-957-2991
1-866-225-0709