Drug recall D-0388-2024

Class II Terminated reported Mar 20, 2024

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.

Lots and codes

Lot #s: SFBG024, SFBG025, Exp. 05/31/2024

Recall details

Recalling firm
Micro Labs Limited, Verna, N/A
Quantity
118,080 bottles
Distribution
Puerto Rico, TN, RI
Type
Voluntary: Firm initiated
Recall initiated
February 9, 2024
Terminated
June 24, 2025