FDA recall D-1097-2018
Northwind Pharmaceuticals LLC · Class II · drug
Product
Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
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-1097-2018