Recall of one lot of Rofact (rifampin) 300 mg due to labelling error - For Health Professionals

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This is duplicated text of a letter from Valeant Canada Limited. Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on ROFACT (rifampin) 300 mg

May 15, 2009

Subject: Risk Associated with Potential Inadvertent Administration of Clonazepam 0.5 Mg Due to Mislabelled Bottles of ROFACT^® 300 mg Capsules (Lot 8K5467 DIN 00343617)

Dear Health Care Professional,

Valeant Canada Limited, in consultation with Health Canada, is advising you about a recall involving the antibiotic ROFACT^® (rifampin) 300 mg Capsules (100's) lot 8K5467, DIN 00343617, expiry date October 2010 because some bottles of ROFACT^® (rifampin) from this lot may be mislabelled and contain clonazepam 0.5 mg tablets instead. ROFACT^® (rifampin) is indicated for the treatment of active tuberculosis disease and latent tuberculosis infection in selected individuals. It is also used for prophylaxis of contacts to a case of meningococcal disease and occasionally for treatment of other infectious diseases. The potential health risks of inadvertent administration of clonazepam instead of ROFACT^® (rifampin) due to the labelling error include the following:

• The directions of use for ROFACT^® would result in the ingestion of two clonazepam tablets of 0.5 mg daily. This may lead to adverse reactions most of which are central nervous system effects such as drowsiness, behavioural symptoms and impaired coordination. Weakness and fatigue might also occur. These adverse reactions may lead to accidents with hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.
• Patients who are receiving clonazepam instead of ROFACT^® as prescribed are not being appropriately treated for tuberculosis, latent tuberculosis infection, prophylaxis for meningococcal disease or treatment of other infectious diseases.

The following is recommended:

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

The mislabelling error was identified due to a complaint received from a pharmacist. The product Clonazepam 0.5 mg Lot 8K5515 (500's), DIN 02270641, expiry date November 2010, was found to be labelled with the ROFACT^® label, due to a labelling error. It is believed that a maximum of four bottles were labelled incorrectly at the factory. Since one bottle was discovered (unused) at the pharmacy level, up to three bottles remain unaccounted for. This lot of ROFACT^® was distributed to wholesalers across Canada from mid-December 2008 to April 9, 2009.

Pharmacists are asked to ensure that any stock of the above-mentioned lot of ROFACT^® be returned to the wholesaler immediately. Wholesalers were advised of this Recall on May 8, 2009 and were requested to contact pharmacists and send out return forms.

As an exception, all government pharmacies and public health units who have ROFACT^® 300 mg from this lot in stock are advised to open all these bottles and to return any to Valeant Canada that do not contain ROFACT^®. Bottles which do contain ROFACT^® (rifampin) 300 mg may be retained to ensure continuity of drug supply. However, government pharmacies and public health units should still fill out the return forms, indicating how much product from the affected lot they have in stock.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected adverse reactions in patients receiving the affected lot of ROFACT^® should be reported to Valeant Canada Limited or Health Canada at the following addresses:

The picture of the drug: ROFACT^® 300 mg can be found on the Valeant Canada web site.

original signed by

Natasha Demberg
Director, Quality Unit
Valeant Canada
1956 Bourdon Street
Montreal, Quebec H4M 1V1