Drug product
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
D-0012-2019
Product summary
- Event
- Event 81099
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2880 bottles
- Official record key
drug-enforcement:D-0012-2019
Official wording
Reason: Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Code information: Lot #: GG80218, Exp. 12/2019
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Potency or specification failure
Subpotent