Canadian generic producer Apotex has a new recall to deal with, this time for nearly 50,000 bottles of a diuretic.
According to the most recent FDA Enforcement Report, the company is recalling one lot of 5 mg torsemide tablets, consisting of 13,179 bottles or 1,317,900 pills. It is also recalling three lots of 20 mg tablets, consisting of 35,819 bottles or 358,190,000 pills.
The report said the tablets were manufactured at Apotex’s plant in Toronto. They are being recalled for cGMP deviations, but the report gave specifics on what those deviations are. The recall began Dec. 14 and was just posted by the FDA.
Apotex had another much larger recall in July when it retrieved about 1.5 million bottles of duloxetine delayed-release capsules, a generic of Cymbalta.
Apotex, perhaps the largest generic drug producer in North America, has a long history of FDA issues. The agency issued a warning letter to Apotex in 2015 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.