FDA recall D-1081-2019

RemedyRepack Inc. · Class II · drug

Product

Losartan 50mg Tablet, 30 count each blister card.

Reason for recall

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Distribution

Product was distributed to one sole customer, Miami, FL.

Key facts

Status: Terminated
Initiation date: 2019-03-14
Report date: 2019-04-17
Termination date: 2019-04-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1081-2019