Teva Recalls Nearly 500,000 Units of Diabetes Drug
Teva Pharmaceutical Industries has issued a Class II voluntarily recall of 499,320 units of glipizide extended-release tablets, 2.5mg, a drug for treating Type 2 diabetes, due to the drug missing the mark on dissolution specifications at the 10-hour testing point. Actavis, the generics business of Allergan that Teva acquired in 2016, initiated the recall 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 Actavis. Actavis was previously acquired by Watson Laboratories in 2012 for EUR 4.25 billion ($4.52 billion).
Source: Food and Drug Administration