Statin Recalled

Dr Reddy’s Laboratories Inc is recalling 28,068 bottles of atorvastatin calcium tablets because samples failed to meet impurity/degradation specifications during routine testing. According to the April 6, 2022, US Food and Drug Administration (FDA) Enforcement Report, testing yielded “out-of-specification results for [a] related substance.”

The recall affects atorvastatin calcium tablets, 80 mg, 90-count bottles (NDC 55111-124-90), from lots T000707, T000756, T000758, and T000759 (Exp. 3/22); T2100600 and T2101075 (Exp. 1/23); and T2102802 (Exp. 7/23). The tablets were manufactured by Dr Reddy’s Laboratories Limited, Srikakulam, India, and distributed throughout the United States.

On March 16, 2022, Dr Reddy’s Laboratories voluntarily initiated the recall, which was designated Class III by the FDA on March 29, 2022. The classification suggests use of the recalled tablets is not likely to cause harm.

Atorvastatin is a prescription statin used to treat high cholesterol and triglyceride levels in the blood.