FDA-Drug2018-08-29Class II

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

A-S Medication Solutions LLC.
Hazard

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

Sold states
Nationwide USA
Affected count
178 bottles
Manufactured in
2401 Commerce Dr, Libertyville, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1109-2018

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