FDA recall D-1046-2019

Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15

Reason for recall

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2019-03-05

Report date

2019-03-27

Termination date

2020-12-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2019