Health Canada

Health Canada

December 24, 2013 11:47 ET

Cobalt Pharmaceuticals Recalls One Lot of Its Anti-Depressant Co-Fluvoxamine (100 mg Tablet): Potential Serious Risk to Health

OTTAWA, ONTARIO--(Marketwired - Dec. 24, 2013) -

The issue:

Cobalt Pharmaceuticals, in consultation with Health Canada, is voluntarily recalling one lot of Co-Fluvoxamine (100 mg) - an anti-depressant - because some bottles may also contain a few ciprofloxacin pills, a prescription antibiotic.

Canadians taking Co-Fluvoxamine who are allergic to ciprofloxacin are at risk of fever, rash, itching, hives, and in rare instances, severe skin reactions. In addition, risks include difficulty breathing, swelling of the tongue or throat, shock, and life-threatening anaphylactoid reactions. Rare cases of allergic reactions have been reported in patients receiving ciprofloxacin, even after one dose.

Who is affected: Canadians with allergies to ciprofloxacin who have used Co-Fluvoxamine. To date, Health Canada has not received any adverse reactions related to the presence of ciprofloxacin pills in bottles of Co-fluvoxamine.

What consumers should do:

- Consult your pharmacist immediately if you are using Co-Fluvoxamine (100 mg) to determine if your prescription is from the recalled lot.

- Do not stop using Co-Fluvoxamine unless advised to do so by your healthcare practitioner.

- Report any adverse events using this product to Health Canada.

What Health Canada is doing:

Health Canada is monitoring the recall of one lot of Co-Fluvoxamine (see below) by Cobalt Pharmaceuticals.

Products affected:

- Co-Fluvoxamine (100 mg) (DIN: 02255537, Lot: 56938A)

How to report side effects of health products to Health Canada:

- Call toll-free at 1-866-234-2345

- Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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