FDA recall D-1108-2018

A-S Medication Solutions LLC. · Class II · 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

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status: Ongoing
Initiation date: 2018-07-17
Report date: 2018-08-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Libertyville, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1108-2018