Valsartan-Hydrochlorothiazide Tablets (A-S Medication) – Carcinogen Impurity (2018)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
A-S Medication Solutions LLC.
Lot Codes / Batch Numbers
Expiry, lot: 4/30/2019: 8033130, 7/31/2019: 8068192, 8110183, 8080157, 8190195
Products Sold
Expiry, lot: 4/30/2019: 8033130; 7/31/2019: 8068192, 8110183, 8080157, 8190195
A-S Medication Solutions LLC. is recalling Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tabl due to CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026