Back to RecallTracker
Health Canada Health products

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

Issued December 24, 2013
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.
What to 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 .