FDA recall D-0788-2022

Product

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

Reason for recall

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

Distribution

Product was distributed to customers in AK and PA.

Key facts

Status

Terminated

Initiation date

2022-04-06

Report date

2022-05-04

Termination date

2022-05-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0788-2022