PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: September 2, 2015 Initiated: August 13, 2015 #D-1378-2015

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.

Reason for Recall

Subpotent Drug: Subpotent atorvastatin.

Details

Units Affected
a) 16,848 and b) 216 Bottles
Distribution
U.S. Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: a) 16,848 and b) 216 Bottles.
Why was this product recalled?
Subpotent Drug: Subpotent atorvastatin.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2015. Severity: Low. Recall number: D-1378-2015.