Apotex recalls three drugs after US import ban
Canada’s largest generic drug manufacturer has voluntarily recalled three of its medications “as a precautionary measure.”
The FDA issued an import alert three weeks ago that essentially banned the import of the pills made in two of Apotex’s plants into the US. It is not clear if the recalled pills were affected by that ban.
The Apotex Inc. recall affects three products and “comes in light of Health Canada’s continuing inspections of Apotex manufacturing facilities in the Greater Toronto Area,” the health agency announced yesterday.
The affected products are apo-meloxicam, used in treatment of rheumatoid arthritis and osteoarthritis; apo-ranitidine, used for treating excess stomach acid; and apo-amilzide, used for maintenance therapy of patients with liver cirrhosis.
The FDA has a strong reach into Canada’s prescription drug market, and non-compliance with their regulations can lead to serious penalties, such as this import ban, even though the company making the product is not technically subject to FDA regulations.
However, considering their customers are in the US, and all pharmaceuticals must adhere to the FDA’s strict standards, there’s no pill to remedy the pain Apotex will feel from import ban from the FDA.
Companies doing business with Apotex need to maintain compliance with this ban as well or they too will face import penalties.
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