Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,

Recall Number: D-1038-2018

Firm: NuCare Pharmaceuticals Inc

Classification: Class II

Status: Terminated

Report Date: 20180815

Initiation Date: 20180730

Termination Date: 20210422

Reason for Recall

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

Product Description

Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,