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Healthcare

UPDATE 1-Apotex recalls certain lots of 3 drugs in Canada

* Apo-Amilzide, Apo-Meloxicam, Apo-Ranitidine recalled

* Recall is voluntary, precautionary

* Health Canada continues inspections of Apotex facilities (Adds company comments)

OTTAWA, Sept 18 (Reuters) - Prescription drugmaker Apotex Inc has recalled certain lots of three products currently on the Canadian market, said Health Canada, which is conducting inspections of the company’s manufacturing facilities in Toronto.

The recall affects selected lots of Apo-Amilzide 5-50 mg, Apo-Meloxicam 7.5 mg and 15 mg, and Apo-Ranitidine 75 mg and 150 mg.

Apo-Amilzide is used to treat symptoms of rheumatoid arthritis and osteoarthritis in adults. Apo-Ranitidine is used to prevent problems associated with excess stomach acid. Apo-Amilzide is used for maintenance therapy for patients with liver cirrhosis with fluid in the abdomen and swelling.

Apotex director of public and government affairs Elie Betito said there are no safety or efficacy problems with the products.

The company launched the recall two weeks ago, he told Reuters, because a review of operating procedures raised questions about whether some processes were followed properly.

He was unable to quantify the volume or value of the recalled drugs, saying it was a small number of batches produced one to two years ago.

The products are sold in other countries, but have different formulations and regulatory requirements, Betito said.

The U.S. Food and Drug Administration warned Apotex in June that if the company failed to correct a number of manufacturing breaches the agency found at the Toronto facilities, the FDA could freeze new drug applications in the United states and ban Apotex products from entering the country.

The FDA charged that Apotex did not thoroughly investigate the failure of batches of some drugs and also noted an unusually high number of rejected batches.

Health Canada said late on Thursday that it would continue inspections of Apotex facilities in Ontario in coming weeks to determine if other products are affected and whether manufacturing standards are being followed.

The company continues to work with Health Canada, whose audit began this week and continues for another two to three weeks, Betito said. (Reporting by Susan Taylor; editing by John Wallace and Peter Galloway)

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