Thursday, May 30, 2013

Various lots of five prescription drugs recalled

Health Canada press release

In consultation with Health Canada, four companies (Cobalt Pharmaceuticals, Laboratoire Riva, Mylan Pharmaceuticals and Sanis Health) are voluntarily recalling various lots of five prescription drugs (amlodipine, ciprofloxacin, lamotrigine, norfloxacin and telmisartan) from the Canadian market (see chart here). The voluntary recall is a precautionary measure due to quality concerns at the manufacturing facility of the active ingredients used in the products. The issues are primarily around processes that affect quality control and oversight.

Patients currently using any of these medications who have concerns should contact their healthcare professional to obtain medical advice. However, patients are advised not to discontinue treatment unless directed by their healthcare professional. Healthcare professionals are encouraged to monitor their patients using any of the recalled product lots and report any adverse reaction potentially related to these products to Health Canada. As of May 27, 2013, Health Canada had not received any adverse reactions associated with the affected products.

Amlodipine is used in the treatment of hypertension (high blood pressure) and angina (chest pain). Ciprofloxacin and norfloxacin are used in the treatment of various infections (acute bronchitis, urinary tract infections, travellers’ diarrhea). Lamotrigine is used in the treatment of epilepsy (seizures). Telmisartan is used in the management of hypertension.

Health Canada will monitor the effectiveness of these recalls. This action is not anticipated to disrupt the overall supply for these products, as alternative manufacturers supplying the Canadian market are not affected.

The European Directorate for Quality of Medicines & HealthCare made Health Canada aware of its recent inspection of Smruthi Organics Limited, India, where the active pharmaceutical ingredients used in the manufacturing of these products are sourced. This inspection highlighted quality system issues that raised concerns about the quality of the pharmaceutical ingredients manufactured at this facility.

Should Health Canada become aware of other affected products or additional lots, the Department will inform Canadians and work with the manufacturers and/or distributors to have the products removed from the marketplace.

The following information will help consumers identify the affected products. Consumers wishing more information regarding a company’s product are encouraged to contact them directly.

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