Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Valsartan and Hydrochlorothiazide Tablets Recalled by A-S Medication Solutions LLC. Due to CGMP Deviations: Carcinogen impurity detected in API used...

Date: July 17, 2018
Company: A-S Medication Solutions LLC.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact A-S Medication Solutions LLC. directly.

Affected Products

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

Quantity: 524 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About A-S Medication Solutions LLC.

A-S Medication Solutions LLC. has 7 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report