Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 5
Recalled August 22, 2018 · FDA recall D-1079-2018 · Dr. Reddy's Laboratories
Hazard
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets. · FDA Class III
Units
2280 bottles
Sold at
U.S.A. Nationwide
Description
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Product
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →