Canadian company recalls antibiotic

15.MAY.09

By J. Soso-Vincent

Canadian pharmaceutical manufacturer Apotex recently withdrew Apo-Clindamycin Hydrochloride 150mg and 300mg, an antibiotic commonly used to treat respiratory tract infections, from the market. The concerned batches carry the batch numbers HL 0314, HT 1470, HY 7888 and JC 7887.{{more}}

In the wake of information received from Health Canada following a joint evaluation by the organisation and Apotex, identified batches of Clindamycin active raw material and certain beta-antibiotics were found to have inadequate separation during manufacturing. Although not categorically confirmed, cross-contamination is thought to be a risk. “Although the potential for serious adverse health consequences was unconfirmed and remote, Apotex is voluntarily recalling the product as a precautionary measure…” the release stated.

Locally, the Chief Pharmacist Joann Ince-Jack confirmed that pharmacies have been notified and the drug recalled. “They’ve already been pulled off the market.” SEARCHLIGHT contacted several pharmacies, which all confirmed this. Others related that they had never stocked Apo-Clindamycin.

According to the Barbados Nation Newspaper (April 21, 2009), the Barbados Drug Service has already returned several batches to the local agent and “is working… to ensure all identified batches of the antibiotic preparation… are returned.”

In Guyana, the Food and Drug Department is calling on all importers, pharmacies and health care providers to surrender said batches of Apo-Clindamycin.

In Canada, the recalled lots were distributed to retail pharmacies, wholesalers, doctors, hospitals and government agencies. Internationally, lots were also dispensed to agents in Antigua, Bahamas, Guyana, Saudi Arabia, Mexico, Haiti, Jamaica, Dominican Republic, Belize and the Dutch Antilles.

Apotex also recalled another drug, Apo-Amoxi-Clav, in April 2008 from other markets. In August 2006, a US District Court prevented the company’s further sale of its generic version of Plavix, a blood thinner manufactured by the pharmaceutical company Sanofi.