Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19

Recall Number: D-1101-2018

Firm: RemedyRepack Inc.

Classification: Class II

Status: Terminated

Report Date: 20180822

Initiation Date: 20180810

Termination Date: 20181012

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

Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19