Apotex Recalls 3 Prescription Drugs

Toronto, Ontario (AHN) – Apotex, Canada’s largest manufacturer of generic medicine, voluntarily recalled three prescription drug as a precautionary measure and in response to an import ban made by the U.S. Food and Drug Administration.

Health Canada identified the three medication as apo-amilzide (5 to 50 mg), apo-meloxicam (7.5 and 15 mg) and apo-ranitidine (75 and 150 mg). The import prohibition by the FDA issued in June was based on multiple and serious deficiencies found by the agency in Apotex’s facility in Etobicoke.

Apo-amilzide is used as maintenance drug for liver cirrhosis patient who are suffering from fluid in the abdomen and swelling. Apo-meloxicam is for treatment of rheumatoid arthritis symptoms and osteoarthritis in adults. Apo-ranitidine is used to treat and prevent problems associated with excess stomach acid.

Because of the FDA ban, Health Canada is conducting inspections of Apotex’s manufacturing plant and coordinating with Apotex to thoroughly review the generic drug firm’s Good Manufacturing Practices. The GMP is the benchmark used to ensure effective overall approach to product quality control and risk management.

Apotex, said in a statement issued on Sept. 8, it is actively working with the FDA to resolve the issues, and the drug company is optimistic the problem will be solved soon. Apotex president and chief operating officer Jack Kay pointed out aside from the three drugs in question, the company has manufactured since 1974 about 200 billion tablets and capsules – considered safe and effective drugs – and sold in more than 115 nations.