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

Starting date:

May 15, 2009

Posting date:

May 21, 2009

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002148

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

Notice about Health Canada advisories

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

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:

• Pharmacists are asked to contact any patient to whom you may have dispensed this lot of ROFACT^® to confirm the appearance of the drug: ROFACT^® 300 mg is a hard gelatin capsule, brown opaque cap & dark red opaque body, branded "ICN R12" whereas clonazepam 0.5 mg is an orange, round, compressed tablet embossed C31 on top and "0.5" underneath on one side and scored on the other. In case of any doubt please ask your patient to bring the product to the pharmacy for verification.
• If there is any doubt or if the patient has received clonazepam in error, the patient must advise their health care professional immediately and not discontinue the medication.
• Physicians treating a patient for active tuberculosis or latent tuberculosis infection, who took clonazepam instead of ROFACT^® (rifampin) since mid-December 2008, are advised to contact their TB control programme for guidance on how to manage the case.
• Physicians are advised to contact their public health unit regarding re-prophylaxis in case of meningococcal disease contact for which the patient has received clonazepam instead of ROFACT^® (rifampin).
• Physicians are asked to advise patients on how to safely withdraw from clonazepam should any of their patients have received this product in error. Please ensure that the patient is treated appropriately for their existing condition for which ROFACT^® was prescribed.

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:

Valeant Canada Limited
Address:4787, Levy Street
Montreal, Quebec, H4R 2P9
Tel: 514-744-6792
1-800 877-879-4567
Fax: 514-744-1842

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Health Product and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

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