FDA recall D-1111-2018

A-S Medication Solutions LLC. · Class II · drug

Product

Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0

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-1111-2018