Drug product
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
D-1376-2015
Product summary
- Event
- Event 71984
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 14,640 and b) 624 Bottles
- Official record key
drug-enforcement:D-1376-2015
Official wording
Reason: Subpotent Drug: Subpotent atorvastatin.
Code information: a) Lot #: C403577, Expiry: 10/2015; b) Lot #: C403577, Expiry: 10/2015.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent