Health Canada Issues Warning for Antibiotic Rofact (Rifampin)

A Small Number of Bottles Contain the Wrong Drug

Health Canada is warning consumers that there is a small possibility that some bottles of one lot of Rofact® (rifampin), an antibiotic used to treat tuberculosis (TB) and some other infections, may contain the drug clonazepam instead of the antibiotic rifampin.

The affected lot number of Rofact® is 8K5467, and the Drug Identification Number (DIN) is 00343617. Clonazepam is an anti-epileptic medication and has sedating properties. The manufacturer, Valeant Canada, is initiating a recall to the retail level.

Consumers who have Rofact® (rifampin) at home are advised to check their bottle of medication and confirm that they have the correct, prescribed drug.

The bottles in question are for Rofact® 300 mg, and were erroneously filled with clonazepam 0.5 mg. Rofact® (rifampin) is an antibiotic used to treat tuberculosis (TB) and some other infections. Rofact® 300 mg are hard capsules, brown and dark red in colour, and marked 'ICN R12' while the clonazepam pills are orange, round tablets and are marked 'c31' and '0.5'.

The side-effects associated with the use of products containing clonazepam vary according to the individual and can include dizziness, drowsiness, muscle weakness, confusion, and loss of memory. Due to the potential for impairment of mental alertness or physical coordination, patients exposed to clonazepam may be at risk of accidents when operating machinery or driving a motor vehicle.

The bottles were mislabelled due to a production error, and it is believed that a maximum of 4 bottles were filled incorrectly at the factory. One was discovered by a pharmacist before any medication was dispensed to a consumer, therefore at most 3 bottles may be on the Canadian market. Prescriptions of Rofact® may be dispensed from a pharmacy in smaller amounts and not in the original bottle. The incorrectly labelled bottles of Rofact® may have been on the Canadian market since December 2008.

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Published on May-15-09