Canada’s Apotex is perhaps the largest generic drug producer in North America and as such ships large quantities of product to the U.S., meaning its recalls can sometimes involve big numbers. In a recently classified event, the drugmaker is recalling nearly 1.5 million bottles of a generic antidepressant.
According to the most recent FDA Enforcement Report, Apotex is voluntarily recalling 1,356,262 30-count bottles of duloxetine delayed-release capsules, a generic of Cymbalta. It is also recalling another 107,880 60-count bottles.
According to the report, Apotex decided to recall them because they were found to be out of specification for dissolution during stability testing. The product was made at the Apotex plant in Toronto. The recall actually began in January, but it took until this week for the FDA to decide it was a Class III recall.
It was also in January when Camarillo, CA-based Golden State Medical Supply began recalling 468 packages of atorvastatin that had been produced for it at the Apotex plant in Toronto. In that case the product had failed impurities testing.
Apotex has had its fair share of FDA issues. The FDA issued a warning letter to Apotex last year for two plants in Bangalore, India. The FDA said the facilities were discovered manipulating testing data, a practice it said had gone on for years.
-access the recall here