A Small Number of Bottles of the Antibiotic Rofact (Rifampin) May Contain a Different Drug

OTTAWA, May 15, 2009 - 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'. If the bottle has the wrong medication (orange round tablets) in it, consumers should contact their treating physician as soon as possible and notify their pharmacist. If there is any doubt, contact the pharmacist.

This photograph (not to scale) shows the correct colour and shape of Rofact® (rifampin) capsules:
This photograph (not to scale) shows the correct colour and shape of Rofact® (rifampin) capsules

Persons who think they may have been mistakenly taking clonazepam instead of Rofact®, (rifampin) any time since the middle of December, 2008 should contact the physician treating them and their public health TB nurse (if they are being treated for tuberculosis) as soon as possible to get the proper medication and treatment advice. However, patients should not stop taking their prescription until directed by their physician. Some patients who suspect that they have mistakenly received clonazepam may need to be gradually taken off the drug to avoid withdrawal symptoms under the supervision of their physician.

Health Canada is working with the Public Health Agency of Canada to notify public health physicians and tuberculosis clinics of this issue.

Clonazepam belongs in the prescription class of drugs known as benzodiazepines. It is indicated for treatment of certain seizure disorders and also prescribed for anxiety and panic disorders. 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 four bottles were filled incorrectly at the factory. One was discovered by a pharmacist before any medication was dispensed to a consumer, therefore at most three 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.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

 

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this Web site.

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709
 

Posted: May 2009


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