FDA recall D-1456-2019

Teva Pharmaceuticals USA · Class II · drug

Product

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Distribution

Nationwide by 4 major distributors.

Key facts

Status: Ongoing
Initiation date: 2019-06-06
Report date: 2019-07-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1456-2019