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Apotex recalls 3 drugs as precaution

Canadian generic drug manufacturer Apotex has voluntarily recalled lots of three drugs as a precaution while Health Canada checks quality-control standards at its manufacturing facilities in Ontario.

A Canadian generic drug manufacturer has voluntarily recalled lots of three drugs as a precaution.

Health Canada said Thursday that Apotex recalled:

  • Apo-Amilzide (5-50 mg), used for maintenance therapy in patients with liver cirrhosis.
  • Apo-Meloxicam (7.5 & 15 mg), used to treat symptoms of rheumatoid arthritis and osteoarthritis.
  • Apo-Ranitidine (75 & 150 mg), used for treating and preventing excess stomach acid.

"This information comes in light of Health Canada's ongoing inspections of Apotex manufacturing facilities in the Greater Toronto Area," the department said in a release.

Health Canada is reviewing the company's facilities in Ontario to verify its quality control standards and risk management for manufacturing, testing, storing, handling and distribution of other products.

FDA alert

"The recall was minor in nature," Apotex said in a statement. "All lots met specifications, and no patient has experienced any problem from taking these medicines."

No other lots or company products are affected by the recall.

The company said it welcomes oversight and dialogue with Health Canada, including site inspections.

Three weeks ago, the U.S. Food and Drug Administration issued an alert banning the export of pills made in two of Apotex's plants to the U.S.

It's not clear whether the three drugs recalled in Canada were affected by the U.S. ban. On Sept. 8, Apotex said it was "actively working with the FDA to resolve the identified concerns as quickly as possible."