Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

Recall Number: D-1378-2015

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class III

Status: Terminated

Report Date: 20150902

Initiation Date: 20150813

Termination Date: 20161215

Reason for Recall

Subpotent Drug: Subpotent atorvastatin.

Product Description

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.