Drug product
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.
D-1378-2015
Product summary
- Event
- Event 71984
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 16,848 and b) 216 Bottles
- Official record key
drug-enforcement:D-1378-2015
Official wording
Reason: Subpotent Drug: Subpotent atorvastatin.
Code information: a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent