Drug product
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
D-0326-2021
Product summary
- Event
- Event 87533
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12288 bottles
- Official record key
drug-enforcement:D-0326-2021
Official wording
Reason: Labeling: Label-mixup
Code information: Lot #: 1905005661, Exp March 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Labeling or packaging
Labeling: Label-mixup