FDA recall D-1109-2018

A-S Medication Solutions LLC. · Class II · 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

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-1109-2018