Drug product
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.
D-1379-2015
Product summary
- Event
- Event 71984
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3840 Bottles
- Official record key
drug-enforcement:D-1379-2015
Official wording
Reason: Subpotent Drug: Subpotent atorvastatin.
Code information: Lot #: C404595, Expiry: 11/2015
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent