Recalls / Class II

Class IID-1098-2018

Product

Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52

Affected lot / code info

Lot: UT48100001, exp 9/30/2019

Why it was recalled

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

Recalling firm

Firm

Northwind Pharmaceuticals LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

9402 Uptown Dr Ste 1100, Indianapolis, Indiana 46256-1042

Distribution

Quantity

14 bottles

Distribution pattern

Indiana

Timeline

Recall initiated

2018-07-18

FDA classified

2018-08-15

Posted by FDA

2018-08-22

Terminated

2023-03-25

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1098-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.