Drug product

Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478

D-1250-2019

April 24, 2019

Class II

Product summary

Firm: AVKARE Inc.
Event: Event 82706
Status: Ongoing
Classification: Class II
Quantity: 846 cartons (42,300 tablets)
Official record key: drug-enforcement:D-1250-2019

Official wording

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.

Code information: Lot: 19554 Exp. 4/30/2019

Distribution pattern: Nationwide

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

impurity, N-Methylnitrosobutyric acid (NMBA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations