Home / Recalls / Micro Labs Limited / D-0388-2024

D-0388-2024 Class II Terminated

Recalled by Micro Labs Limited — Verna, N/A

Recall Details

Product Type: Drugs
Report Date: March 20, 2024
Initiation Date: February 9, 2024
Termination Date: June 24, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 118,080 bottles

Product Description

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.

Distribution Pattern

Puerto Rico, TN, RI

Code Information

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