Generic Manufacturer Recalls Product
Apotex, a Canadian generic drug manufacturer, as a precautionary measure has put out a voluntary recall for several product batches of one of its products from the Australian market.
The recall comes after Apotex received several warnings from the US Food and Drug Administration (FDA) that two of its plants in Toronto, Canada were in breach of accepted manufacturing processes.
The manufacturer is also voluntarily recalling 40-medicines from the US market, three from the Canadian market, with both US and New Zealand temporarily restricting imports from the two plants in question.
A Therapeutic Goods Administration (TGA) spokeswoman says, while not patient safety concerns have been identified, the situation is being monitored together with other regulatory authorities.
Apotex brands include APO, GenRx, Chemmart Private Label and Terry White Chemists Private Label.
Health Canada in its news release says, the recall applies to three drug lots, including Apo-Amilzide (5 to 50-mg), Apo-Meloxicam (7.5 and 15-mg) and Apo-Ranitidine (75 and 150-mg), medications for treating rheumatoid arthritis, osteoarthritis, excess stomach acid or liver cirrhosis.
Apotex facilities will continue to be inspected for the next few weeks to ensure compliance with manufacturing standards.
Apotex is the largest Canadian-owned pharmaceutical company, producing over 260-generic drugs that are distributed in Canada, including being exported to over 115- countries.
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