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Health professional risk communication

APO-CEPHALEX (cephalexin) - Recall Due to Possible Reduced Efficacy - For Health Professionals

Starting date:
June 24, 2013
Posting date:
June 24, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Quality, Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-34291

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on APO-CEPHALEX

June 24, 2013

Wholesalers and Distributors are requested to forward this letter to their direct account Health Care Professionals whom they have shipped the affected APO-CEPHALEX Lot(s) to.

Dear Health Care Professional,

Subject: Recall of APO-CEPHALEX (cephalexin) due to possible reduced drug efficacy (DINs: 00768715 and 00768723) 

Apotex Inc., in consultation with Health Canada, is writing to advise you that Apotex has initiated a recall for two lots of APO-CEPHALEX (cephalexin); the lot numbers are JP6665 for APO-CEPHALEX 250 MG and JP1017 for APO-CEPHALEX 500 MG tablets. Inadvertent exposure of these APO-CEPHALEX tablets to rain water may have caused tablets to partially dissolve and have a decreased active drug content which may in turn result in reduced drug efficacy.

APO-CEPHALEX is indicated for the treatment of bacterial infections of the respiratory tract, otitis media, genitourinary tract, bones and joints, skin and soft tissues when the infection is caused by susceptible organisms.

  • Due to an inadvertent exposure to rain water, some lots of APO-CEPHALEX 250 MG and APO-CEPHALEX 500 MG may have decreased active drug content that could lead to reduced drug efficacy.
  • Pharmacists should stop dispensing any of this affected product and replace recent dispensed prescriptions with unaffected product.

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. Serious or unexpected adverse reactions in patients receiving APO-CEPHALEX should be reported to Apotex or Health Canada.

If you have a medical enquiry about APO-CEPHALEX, please contact the Apotex’s Drug Information Service as per the contact information below:

APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Phone: 1-800-667-4708
Fax: 1-416-401-3884

To report an adverse drug reaction with APO-CEPHALEX, please contact Apotex Drug Safety department as per the contact information below:

APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Phone: 1-800-667-4708
Fax: 1-416-401-3819
Email: Drugsafety@apotex.com

To correct your mailing address or fax number, contact Apotex Inc.

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 
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

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

Yours sincerely,

original signed by

Colin D'Cunha MBBS, MHSc, FRCPC
Director, Global Medical Affairs
Apotex Inc.