D-0388-2024 Class II Terminated
FDA drug recall D-0388-2024 was initiated by Micro Labs Limited on February 9, 2024 and is designated Class II. Reason for recall: Failed Stability Specifications: Out of specification for blend uniformity. The recall status is terminated (terminated June 24, 2025). Affected quantity: 118,080 bottles.
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