Drug product
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count bottle (NDC 43598-321-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
D-1144-2015
Product summary
- Event
- Event 71375
- Status
- Terminated
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1144-2015
Official wording
Reason: Subpotent drug
Code information: Lot #: a) C401537, Exp 07/2015; b) C401539, Exp 07/2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent