Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

Recall Number: D-0419-2018

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180207

Initiation Date: 20180129

Termination Date: 20181207

Reason for Recall

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Product Description

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05