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| Apotex's Bangalore facility--Courtesy of Apotex |
Canadian generics maker Apotex is recalling more than 35,000 bottles of generic Zyprexa, an antipsychotic, that were manufactured at a plant in Toronto that was recently nicked by the FDA for a number of issues.
The class III recall includes olanzapine in 5-mg, 10-mg and 200-mg doses. According to the latest FDA Enforcement report, Apotex began voluntary recalling the products in April after testing revealed they may be subpotent.
The FDA raised concerns at an Apotex plant in Ontario last fall, citing it for failing to keep equipment clean and for not having password-protected computers that could prevent employees from altering or deleting testing data.
Apotex has had problems meeting FDA standards for years. In April 2014, the agency banned an Apotex plant in India after discovering it had repeatedly faked test data. In November the drugmaker recalled 65,442 bottles of candesartan cilexetil made at the Bangalore plant when testing found it contained excessive levels of impurities. Canadian authorities banned the same plant after reviewing the FDA information.
The FDA issued import alerts on Apotex plants in Toronto and Quebec from 2009 to 2011. Apotex later unsuccessfully sued the agency through the North American Free Trade Agreement for disrupting its business.
- the FDA notices are here, here and here