Cobalt Pharmaceuticals recalls one lot of its anti-depressant Co-Fluvoxamine (100 mg tablet): potential serious risk to health

Starting date:

December 24, 2013

Posting date:

December 24, 2013

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-37389

• Issue
• Products affected
• What you should do
• Who is affected
• Report health or safety concerns
• Media enquiries
• Public enquiries
• What Health Canada is doing

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.

Products affected

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

What you should do

If you have a known allergy to ciprofloxacin you should stop taking the medication and confirm with a healthcare practitioner whether it is from an affected lot. Otherwise 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.

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.

Report health or safety concerns

• 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.

 

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

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