Drug product
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
D-0388-2024
Product summary
- Event
- Event 93965
- Status
- Terminated
- Classification
- Class II
- Quantity
- 118,080 bottles
- Official record key
drug-enforcement:D-0388-2024
Official wording
Reason: Failed Stability Specifications: Out of specification for blend uniformity.
Code information: Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
Distribution pattern: Puerto Rico, TN, RI
Derived failure modes
-
Potency or specification failure
Out of specification