Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

Recall Number: D-1108-2018

Firm: A-S Medication Solutions LLC.

Classification: Class II

Status: Ongoing

Report Date: 20180829

Initiation Date: 20180717

Termination Date:

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

Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China