D-1095-2018 Class II Terminated
FDA drug recall D-1095-2018 was initiated by Northwind Pharmaceuticals LLC on July 18, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. The recall status is terminated (terminated March 25, 2023). Affected quantity: 68 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 22, 2018
- Initiation Date
- July 18, 2018
- Termination Date
- March 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68 bottles
Product Description
Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution Pattern
Indiana
Code Information
Lot: UT48320002, exp 07/31/2018; Lot UT48320003, exp 05/31/2019