FDA recall D-0388-2024

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.

Distribution

Puerto Rico, TN, RI

Key facts

Status

Terminated

Initiation date

2024-02-09

Report date

2024-03-20

Termination date

2025-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Verna, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0388-2024