Recalls / Class II
Class IID-1095-2018
Product
Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
- Affected lot / code info
- Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019
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
- 68 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-1095-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.