A-S Medication Solutions LLC. recalls Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx O
Recalled August 29, 2018 · FDA recall D-1110-2018 · A-S Medication Solutions
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
524 bottles
Sold at
Nationwide USA
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
Manufacturer(s)
A-S Medication Solutions LLC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →