Micro Labs Limited: Drug Recall

Recall #D-0388-2024 · 02/09/2024

Class II: Risk

Recall Details

Recall Number
D-0388-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Micro Labs Limited
Status
Terminated
Date Initiated
02/09/2024
Location
Verna, N/A, India
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
118,080 bottles

Reason for Recall

Failed Stability Specifications: Out of specification for blend uniformity.

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.

Distribution Pattern

Puerto Rico, TN, RI

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.