Three companies voluntarily recalling all lots of their antipsychotic medication due to possible contamination issues

In consultation with Health Canada, three companies (Cobalt Pharmaceuticals Company, Laboratoires Riva Inc. and Sanis Health Inc.) are voluntarily recalling all lots of their antipsychotic product (Quetiapine) due to potential contamination with an antibiotic product (Clindamycin) during the manufacturing process. The recall affects the 25 mg, 100 mg, 200 mg and 300 mg doses of Co Quetiapine, Riva Quetiapine, and Sanis Quetiapine.

Quetiapine is used in the treatment of schizophrenia and bipolar disorder in adult patients. As advised by Health Canada and the affected companies, Shoppers Drug Mart/Pharmaprix pharmacists will be contacting patients who have received this medication and will be advising them to return the medication and safely transition to an alternative authorised quetiapine product. Patients and caregivers can contact their Shoppers Drug Mart/Pharmaprix pharmacists for further information.

Who is affected:

As of May 17, 2013, Health Canada has not received any adverse reactions associated with the possibility of contamination of Quetiapine and Clindamycin.

The population at risk includes those who are susceptible or hypersensitive to the antibiotics clindamycin or lincomycin. The risks include mild skin rashes; however, hives and in rare instances more serious skin disorders resembling Stevens-Johnson syndrome (a more severe rash with blisters and peeling skin), and a few cases of anaphylactoid reactions have also been reported during drug therapy with clindamycin.

What patients should do:

  • Immediately contact your Shoppers Drug Mart/Pharmaprix pharmacist with any questions or concerns regarding the use of quetiapine products.
  • Do not discontinue treatment and contact your health care professional to obtain medical advice.
  • Report any adverse reaction potentially related to these products to Health Canada .
  • Contact Health Canada’s toll-free line at 1-800-267-9675 with questions or complaints about these products.

For most adult patients, exposure to trace amounts of clindamycin hydrochloride will not represent a health risk and there are no contraindications for taking the two medications together. However, for those who may have hypersensitivity to clindamycin (estimated at less than 1% of the population), even trace amounts may cause serious allergic reactions.

Products affected:

All lots of 25 mg, 100 mg, 200 mg and 300 mg doses of Co Quetiapine (Cobalt Pharmaceuticals Company), Riva Quetiapine (Laboratoires Riva Inc.), and Sanis Quetiapine (Sanis Health Inc.)

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Health Canada Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.