Recalling firm
Micro Labs Limited
Product type
Drug
Status
Terminated
Report date
2024-03-20
Distribution
Puerto Rico, TN, RI
Firm state
N/A
Product quantity
118,080 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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.
Code / lot info
Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.