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.
FDA recall notice · announced March 20, 2024 · Micro Labs Limited
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Failed Stability Specifications: Out of specification for blend uniformity.
Notes
Distribution: Puerto Rico, TN, RI
Lot/code information: Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
Quantity: 118,080 bottles
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.