FDA recall D-0789-2022

Product

Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.

Reason for recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Distribution

Nationwide within the U.S to CA, IN and FL.

Key facts

Status

Terminated

Initiation date

2022-04-12

Report date

2022-05-04

Termination date

2022-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0789-2022