More signs of manufacturing trouble at Apotex. The generics maker is recalling lots of three drugs in Canada: Apo-Amilzide, liver cirrhosis treatment; Apo-Meloxicam, an arthritis remedy and generic version of Abbott Labs' Mobic; and Apo-Ranitidine, a stomach-acid drug and generic form of GlaxoSmithKline's Zantac. The move comes as Health Canada, like the FDA, is scrutinizing Apotex's manufacturing facilities.
The agency said that other products may join the recall queue if problems are revealed during its ongoing inspections at Apotex's plants. An agency spokeswoman told Reuters that there are no safety or efficacy problems with the three recalled products. A review of operating procedures raised questions about whether certain manufacturing processes were properly followed.
Apotex has been wrangling with the FDA over manufacturing breaches inspectors found at company facilities in the Toronto area. Three weeks ago, the FDA imposed an "import alert," banning export of pills made in those facilities to the U.S. The agency said Apotex didn't investigate some batch failures thoroughly and that it had produced an abnormally high number of failed batches. If the company doesn't fix the manufacturing problems, it could see its approval applications at FDA frozen until it does.
*Editor's Note: The headline of this article originally stated that Health Canada forced the drug recall. Apotex voluntarily recalled the drugs in question.