FDA-Drug2018-08-29Class II
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
A-S Medication Solutions LLC.
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Sold states
Nationwide USA
Affected count
531 bottles
Manufactured in
2401 Commerce Dr, Libertyville, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1111-2018Don't want to check this manually?
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