This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health professional risk communication

Rifadin (rifampin capsules USP) - Voluntary Recall of One Lot Due to Capsules Under Fill Weight - For Health Professionals

Starting date:
March 14, 2013
Posting date:
March 19, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-26171

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Rifadin 150 mg capsules

March 14, 2013

Dear Health Care Professionals,

Subject: Recall of Rifadin® (rifampin capsules USP) 150 mg, bottle of 100 capsules, lot number 3099036 (DIN 02091887) - Limited number of capsules found to be under fill weight.

Sanofi-aventis Canada Inc. (Sanofi Canada) in consultation with Health Canada, would like to inform you of a voluntary recall of one (1) lot (3099036) of Rifadin® (rifampin capsules USP), 150 mg, bottle of 100 capsules with an expiration date of March 2014, to the retail level, due to finding under fill weight capsules in retain samples.

  • The recall is a precautionary measure due to low fill weight of a limited number of Rifadin® 150 mg capsules. Only one lot 3099036 is affected by this recall.
  • Sanofi Canada would like to remind Health Care Professionals to monitor their patients carefully, particularly those who might have received Rifadin® 150 mg capsules from this lot for the prophylaxis of bacterial meningitis.
  • The probability of adverse health consequences for the patient is low.
  • Any remaining stock of this lot must be returned to Sanofi Canada.

Rifadin® is indicated in the treatment of tuberculosis and in the prophylaxis of bacterial meningitis or carriage of N. meningitidis or H. influenza b in persons exposed to a primary case. Rifadin® is available in 150 mg and 300 mg capsules.

Following a review of a limited number of Rifadin® retain samples, a low number of 150 mg capsules (2 - 3%) were found to have a low fill weight. Based on this information, Sanofi Canada has decided to initiate a voluntary recall of the single lot impacted (lot 3099036) as a precautionary measure.

The probability of adverse health consequences for the patients for the approved indications is low. Nonetheless, there is a potential risk of patients having received a lower dose if they were treated with Rifadin® capsules 150 mg from lot 3099036. Sanofi Canada would like to remind the Health Care Professionals to monitor their patients carefully, particularly those who might have received Rifadin® 150 mg capsules from this lot for the prophylaxis of bacterial meningitis.

Drug Recall Forms have been sent to wholesalers, hospital pharmacies and retail pharmacies. Any remaining stock of the recalled lot must be returned to Sanofi Canada. Other lots of Rifadin® 150 mg capsules and Rifadin® 300 mg capsules are not affected by this recall.

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 case of lack of efficacy or other serious or unexpected adverse reactions in patients receiving Rifadin® should be reported to Sanofi Canada or Health Canada.

Sanofi Canada
2905 Place Louis R.-Renaud, Laval
Quebec, Canada
H7V 0A3
Phone: 1-800-265-7927

To correct your mailing address or fax number, contact Sanofi Canada.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or

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

Sanofi Canada is fully committed to patient safety and the health and wellbeing of patients of Rifadin®. We regret any inconvenience that this recall may cause you.

If you have any questions or concerns regarding this drug recall or the content of this letter, please do not hesitate to call our Customer Service at 1-800-265-7927.

Sincerely,

original signed by

Franca Mancino
Vice-President, Medical and Regulatory Affairs