Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China

Recall Number: D-1109-2018

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, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China