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Health professional risk communication

Co Quetiapine (quetiapine fumarate) - Voluntary Recall Due to Possible Contamination Issues - For Health Professionals

Starting date:
May 17, 2013
Posting date:
May 21, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Contamination
Audience:
Healthcare Professionals
Identification number:
RA-29295

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Co Quetiapine (quetiapine fumarate) tablets

May 17, 2013

Dear Health Care Professional,

Subject: Voluntary recall of Co Quetiapine (quetiapine fumarate) 25 mg (DIN 02316080), 100 mg (DIN 02316099), 200 mg (DIN 02316110) and 300 mg tablets (DIN 02316129) due to potential presence of trace amounts of Clindamycin hydrochloride in the tablets.

Cobalt Pharmaceuticals Company, in consultation with Health Canada, is writing to advise you that the supplier of quetiapine fumarate active pharmaceutical ingredient (API) to Cobalt Pharmaceuticals Company may have inadvertently caused trace amounts of clindamycin hydrochloride to be present in the quetiapine raw material. Exposure to clindamycin, no matter how minor, may increase the risk of potentially serious allergic adverse drug reactions, in people taking Co Quetiapine tablets, particularly in those who are allergic or may also be sensitive to clindamycin hydrochloride or lincomycin hydrochloride. Quetiapine is an antipsychotic agent indicated for the management of schizophrenia and bipolar disorder in adult patients and is not indicated for use in patients who are under 18 years of age.  A voluntary recall has been initiated for Cobalt quetiapine products currently on the Canadian market and a list of the affected lot numbers is attached to this letter.

The population at risk is those who are susceptible or hypersensitive to clindamycin hydrochloride or lincomycin hydrochloride. The most common hypersensitivity reaction is generalized mild to moderate morbilliform-like (maculopapular) skin rashes. However, vesiculobullous rashes, urticaria, rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, and a few cases of anaphylactoid reactions have also been reported during drug therapy with clindamycin at recommended doses. 

  • A voluntary recall of Cobalt quetiapine products has been initiated due to potential for trace amounts of clindamycin in affected quetiapine products and possible risk of serious allergic adverse reactions, particularly in those who are hypersensitive to clindamycin or lincomycin.
  • Health care professionals are advised to contact their patients who have been supplied with any Cobalt quetiapine product and ensure a safe transition over to an alternative quetiapine product which is not subject to recall or, to another product authorised for the Canadian market. Increased monitoring is recommended during the transition period.
  • Patients should not abruptly discontinue their treatment but contact their health care professional to obtain medical advice.

During a recent inspection by international inspectors from the European Directorate for the Quality of Medicines & HealthCare (EDQM), it was noted that the API manufacturer’s cleaning records for a piece of common equipment were found inadequate.  While there is no evidence indicating the Quetiapine fumarate product was in contact with clindamycin hydrochloride and, no allergic reaction adverse events have been reported to date, the presence of trace amounts of clindamycin hydrochloride on that common equipment has not yet been ruled out.  As a precaution, it is necessary to bring the possibility of a serious allergic reaction in patients sensitive to clindamycin hydrochloride to your attention. 

For most adult patients, exposure to trace amounts of clindamycin hydrochloride will not represent a health risk. However, the data in the literature indicates a possibility of hypersensitivity in some patients. The prevalence of clindamycin hypersensitivity is expected to be less than 1%.

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 serious allergic reaction or other serious or unexpected adverse reactions in patients receiving Co Quetiapine tablets should be reported to Cobalt Pharmaceuticals Company or Health Canada.

Cobalt Pharmaceuticals Company
Mississauga, ON, Canada
L5N 2B8
1-866-254-6111

To correct your mailing address or fax number, contact Cobalt Pharmaceuticals Company. 

You can also 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, contact Health Canada at:
Lead Directorate: Health Product and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 613-946-5636 

Please be assured that the health and safety of your patients is our primary concern.  

Sincerely,

Original signed by

Bob MaGee
Director, Quality and Compliance

References:

  1. Co Quetiapine (Quetiapine fumarate) Tablets, Product Monograph , revised February 15, 2012
  2. DALACIN C, (Clindamycin Hydrochloride Capsules USP) Product Monograph, revised November 8, 2012
  3. US Prescribing Information. Clindamycin Hydrochloride Capsules. Actavis, Inc. September 2012. 
  4. Mazur N, Greenberger PA, Regalado J. Clindamycin hypersensitivity appears to be rare. Ann Allergy Asthma Immunol. May 1999;82(5):443-5

 

Lots Affected by recall
Lot Description Lot Description
BZ731 CO QUETIAPINE 200 MG 100S CP921 CO QUETIAPINE 25 MG 100S
BZ732 CO QUETIAPINE 200 MG 500S CP932 CO QUETIAPINE 25 MG 500S
BZ741 CO QUETIAPINE 100 MG 100S CP941 CO QUETIAPINE 25 MG 100S
BZ742 CO QUETIAPINE 100 MG 500S CP951 CO QUETIAPINE 25 MG 500S
BZ751 CO QUETIAPINE 100 MG 100S CP971 CO QUETIAPINE 100 MG 500S
BZ761 CO QUETIAPINE 25 MG 500S CP97A CO QUETIAPINE 100 MG 100S
BZ771 CO QUETIAPINE 25 MG 100S CP981 CO QUETIAPINE 100 MG 500S
CC921 CO QUETIAPINE 200 MG 500S CP991 CO QUETIAPINE 300 MG 100S
CC941 CO QUETIAPINE 300 MG 500S CP992 CO QUETIAPINE 300 MG 500S
CC942 CO QUETIAPINE 300 MG 100S CR231 CO QUETIAPINE 200 MG 100S
CD671 CO QUETIAPINE 25 MG 100S CR232 CO QUETIAPINE 200 MG 500S
CD681 CO QUETIAPINE 25 MG 500S CT121 CO QUETIAPINE 25 MG 500S
CD692 CO QUETIAPINE 25 MG 500S CT131 CO QUETIAPINE 25 MG 100S
CD702 CO QUETIAPINE 25 MG 100S CU131 CO QUETIAPINE 100 MG 100S
CD711 CO QUETIAPINE 100 MG 500S CU561 CO QUETIAPINE 200 MG 100S
CD721 CO QUETIAPINE 100 MG 100S CU571 CO QUETIAPINE 200 MG 500S
CD732 CO QUETIAPINE 100 MG 100S CW301 CO QUETIAPINE 300 MG 100S
CD741 CO QUETIAPINE 100 MG 100S CW302 CO QUETIAPINE 300 MG 500S
CG823 CO QUETIAPINE 25 MG 500S CW341 CO QUETIAPINE 100 MG 100S
CG831 CO QUETIAPINE 25 MG 500S CW361 CO QUETIAPINE 25 MG 500S
CG851 CO QUETIAPINE 300 MG 100S CZ501 CO QUETIAPINE 25 MG 100S
CG852 CO QUETIAPINE 300 MG 500S CZ772 CO QUETIAPINE 200 MG 100S
CG861 CO QUETIAPINE 200 MG 100S CZ781 CO QUETIAPINE 300 MG 500S
CG872 CO QUETIAPINE 200 MG 500S CZ782 CO QUETIAPINE 300 MG 100S
CG881 CO QUETIAPINE 200 MG 100S DC171 CO QUETIAPINE 25 MG 100S
CG891 CO QUETIAPINE 100 MG 100S DC181 CO QUETIAPINE 100 MG 500S
CG902 CO QUETIAPINE 100 MG 100S DC191 CO QUETIAPINE 100 MG 100S
CH251 CO QUETIAPINE 100 MG 500S DD531 CO QUETIAPINE 25 MG 500S
CJ725 CO QUETIAPINE 300 MG 500S DD541 CO QUETIAPINE 25 MG 500S
CJ726 CO QUETIAPINE 300 MG 100S DD551 CO QUETIAPINE 25 MG 500S
CK24A CO QUETIAPINE 25 MG 100S DD561 CO QUETIAPINE 25 MG 500S
CK24B CO QUETIAPINE 25 MG 100S DD571 CO QUETIAPINE 25 MG 500S
CK25A CO QUETIAPINE 25 MG 500S DD581 CO QUETIAPINE 25 MG 500S
CK27A CO QUETIAPINE 100 MG 100S DD591 CO QUETIAPINE 100 MG 100S
CK28A CO QUETIAPINE 100 MG 100S DD701 CO QUETIAPINE 200 MG 100S
CK29B CO QUETIAPINE 100 MG 500S DD711 CO QUETIAPINE 200 MG 100S
CL821 CO QUETIAPINE 100 MG 100S DD971 CO QUETIAPINE 300 MG 100S
CM681 CO QUETIAPINE 25 MG 500S DF441 CO QUETIAPINE 25 MG 100S
CM69A CO QUETIAPINE 25 MG 500S DF442 CO QUETIAPINE 25 MG 500S
CM761 CO QUETIAPINE 100 MG 100S DG011 CO QUETIAPINE 200 MG 100S
CM772 CO QUETIAPINE 100 MG 500S DG012 CO QUETIAPINE 200 MG 500S
CM781 CO QUETIAPINE 200 MG 100S DG171 CO QUETIAPINE 25 MG 500S
CM791 CO QUETIAPINE 200 MG 500S DG183 CO QUETIAPINE 25 MG 500S
CM801 CO QUETIAPINE 300 MG 100S DG192 CO QUETIAPINE 100 MG 500S
CM811 CO QUETIAPINE 300 MG 500S DG201 CO QUETIAPINE 100 MG 100S
CM82D1 CO QUETIAPINE 300 MG 100S DK891 CO QUETIAPINE 25 MG 500S
CP91A CO QUETIAPINE 25 MG 100S DK92A CO QUETIAPINE 25 MG 500S