Cobalt Pharmaceuticals said it is voluntarily recalling one lot of Co-Fluvoxamine (100 mg) because it may also contain a few pills of the antibiotic ciprofloxacin.
"Canadians taking Co-Fluvoxamine who are allergic to ciprofloxacin are at risk of fever, rash, itching, hives, and in rare instances, severe skin reactions," Health Canada said in a release on Tuesday.
The affected product is Co-Fluvoxamine (100 mg) (DIN: 02255537, Lot: 56938A).
"If you have a known allergy to ciprofloxacin you should stop taking the medication and confirm with a health-care practitioner whether it is from an affected lot," the department advised.
Otherwise, people should not stop using Co-Fluvoxamine unless advised to do so by a health-care practitioner.
Other risks include difficulty breathing, swelling of the tongue or throat, shock, and life-threatening reactions.
Rare cases of allergic reactions have been reported in patients who take ciprofloxacin, even after one dose, Health Canada said.
The regulator has not received any reports of adverse reactions.