Drug product

Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10

D-1290-2019

May 03, 2019

Class II

Product summary

Firm: Heritage Pharmaceuticals, Inc.
Event: Event 82782
Status: Terminated
Classification: Class II
Quantity: 3697 bottles
Official record key: drug-enforcement:D-1290-2019

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 at the manufacturer

Code information: CLO17014A exp 12/2019 CLO17015A exp 01/2020 CLO17016A exp 01/2020 CLO17017A exp 01/2020 CLO18001A exp 01/2020 CLO18002B exp 01/2020

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