Actavis Inc,, part of Teva Pharmaceutical Industries, has issued a Class II voluntarily recall of 499,320 units of glipizide extended-release tablets, 2.5 mg, a drug for treating Type 2 diabetes, due to failed dissolution specifications, specifically for being.above out of specification for the dissolution rate observed at the 10-hour testing point. Teva acquired Actavis Generics, the generics business of Allergan in 2016.
The recall was initiated in January 2017. The recall was noted by the US Food and Drug Administration (FDA) on February 15, 2017.
A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, according to the FDA.
The recall applies to 12 lots of the product in 30-count bottles manufactured by Patheon Pharmaceuticals, a contract development and manufacturing organization, at its facility in Cincinnati, Ohio.
Teva’s glipizide, which is manufactured under a Watson Laboratories brand, is a generic version of Pfizer’s Glucotrol (glipizide), which was approved as a new molecular entity in 1984 and is indicated for improving glycemic control in adults with Type 2 diabetes mellitus. Teva gained the drug as part of its $40.5-billion acquisition of the generics business of Allergan in 2016..Actavis had acquired Allergan in 2015 and later took the Allergan name as its corporate name. Actavis was acquired by Watson Laboratories in 2012 and kept the Actavis name following the acquisition.
Source: Food and Drug Administration