Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd
Recalled February 7, 2018 · FDA recall D-0418-2018 · Dr. Reddy's Laboratories
Hazard
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability · FDA Class III
Units
a) 34,125; b) 3,540 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Product
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →