FDA recall D-1096-2018

Northwind Pharmaceuticals LLC · Class II · drug

Product

Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution

Indiana

Key facts

Status: Terminated
Initiation date: 2018-07-18
Report date: 2018-08-22
Termination date: 2023-03-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1096-2018