Drug product
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
D-0899-2023
Product summary
- Event
- Event 92618
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,096 bottles
- Official record key
drug-enforcement:D-0899-2023
Official wording
Reason: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Code information: Lot #: A102887, Exp. 6/2023
Distribution pattern: Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
Derived failure modes
-
Potency or specification failure
Subpotent