Actavis pulls Patheon-made pills
- Generic drug maker Actavis pulled five lots of the diabetes drug glipizide, a generic version of Glucotrol, after the pills failed dissolution tests.
- The drugs were being made by contract manufacturing organization Patheon Pharmaceuticals at its facility in Cincinnati, Ohio.
- Actavis, a generic drug unit of Allergan, was recently sold to Teva Pharmaceuticals from Allergan for $40 billion.
An event report from the U.S. Food and Drug Administration showed 167,152 bottles of glipizide 2.5mg extended release tablets had to be recalled, affecting five lots of the drug.
The report did not detail what the problem had been, but Patheon told In-Pharma Technologist that the recall was due to a switch in packaging.
"It was determined following a joint review of the product by the client and Patheon that the dissolution of the product was impacted by the increase in the bottle size and addition of a desiccant. The client initiated a voluntary recall. The client switched back to the previous packaging configuration and Patheon resumed production of the product in July," said a Patheon spokesperson in an email.
This is not the first time this medication has been recalled for dissolution issues. Pfizer, the maker of the branded version, has faced similar recalls in the past, according to the FDA's event reporting system.
This story was updated to include comments from Patheon after it was originally published.
- In-Pharma Technologist Actavis pulls Patheon-made diabetes pills after out-of-spec tests
Follow Lisa LaMotta on Twitter