FDA recall D-0253-2015

Micro Labs Usa, Inc S · Class II · drug

Product

LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10

Reason for recall

Failed Content Uniformity Specifications; Dry mix failed blend uniformity.

Distribution

U.S. Including: New York

Key facts

Status: Terminated
Initiation date: 2014-09-22
Report date: 2014-11-26
Termination date: 2015-12-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0253-2015