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

Recall Number: D-1456-2019

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Ongoing

Report Date: 20190717

Initiation Date: 20190606

Termination Date:

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

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