Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Recall Number: D-0291-2021
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class III
Status: Terminated
Report Date: 20210310
Initiation Date: 20210219
Termination Date: 20230907
Reason for Recall
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Product Description
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA