Drug product

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54

D-1263-2019

April 24, 2019

Class II

Product summary

Firm: Legacy Pharmaceutical Packaging LLC
Event: Event 82710
Status: Ongoing
Classification: Class II
Quantity: 60,012 bottles
Official record key: drug-enforcement:D-1263-2019

Official wording

Reason: CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)

Code information: Lot 181598; 02/2021

Distribution pattern: TN, AZ

Derived failure modes

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

NMBA) impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations