Dr Reddy’s Laboratories, an Indian multinational pharmaceutical company, is recalling from the USA over 236,000 bottles of Atorvastatin Calcium tablets used for lowering cholesterol, according to a report by the US regulator.
Dr Reddy’s Labs Inc is recalling 230,000 bottles of the calcium tablets on account of “failed impurities/degradation specifications,” FDA said in its Enforcement Report. These recalled tablets are in the strengths of 10 mg, 20 mg and 40 mg.
The firm is also recalling 6,397 bottles of 80 mg on account of “presence of foreign substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle,” the report said.
The tablets were manufactured by Dr. Reddy’s Labs at its Srikakulam (India) facility. The voluntary recall for the 10 mg, 20 mg and 40 mg tablets from the U.S. and Puerto Rico is a class III recall. For the 80 mg tablets, the recall is of class II.
A class II recall is initiated in 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 U.S. FDA. A class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.