Dr. Reddy’s Laboratories Ltd. is recalling over 2.36 lakh bottles of Atorvastatin Calcium tablets, used for lowering cholesterol, from the U.S., according to a report by the U.S. health regulator.
Dr. Reddy’s Labs Inc. is recalling 2.30 lakh bottles of the calcium tablets on account of “failed impurities/degradation specifications”, the U.S. Food and Drug Administration said in its enforcement report.
Of the total bottles being recalled, 55,126 are of 10 mg strength, 44,894 bottles of 20 mg and 1,30,081 bottles are of 40 mg, it said. 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 facility, it said. 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, the drug regulator said.
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.