Drug product
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India
D-1377-2015
Product summary
- Event
- Event 71984
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 16,080 and b) 480 Bottles
- Official record key
drug-enforcement:D-1377-2015
Official wording
Reason: Subpotent Drug: Subpotent atorvastatin.
Code information: a) Lot #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent