Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
Recall Number: D-1021-2018
Firm: RemedyRepack Inc.
Classification: Class II
Status: Terminated
Report Date: 20180808
Initiation Date: 20180717
Termination Date: 20181017
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product Description
Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701