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

Recall Number: D-1110-2018

Firm: A-S Medication Solutions LLC.

Classification: Class II

Status: Ongoing

Report Date: 20180829

Initiation Date: 20180717

Termination Date:

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