Drug product

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.

D-1051-2019

March 06, 2019

Class II

Product summary

Firm: Preferred Pharmaceuticals, Inc
Event: Event 82335
Status: Terminated
Classification: Class II
Quantity: 530
Official record key: drug-enforcement:D-1051-2019

Official wording

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

Code information: Count, lots, expiry: a) 30-count bottle C2218C, exp 9/2020, D1318E, exp 10/2020; b) 90-count bottle C2719J, exp 9/2020, E1818B, exp 10/2020.

Distribution pattern: California, Georgia, Indiana

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