Reported Aug 29, 2018 · Ongoing

Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx…

A-S Medication Solutions LLC.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: A-S Medication Solutions LLC. · 2401 Commerce Dr · Libertyville, IL · 60048-4464

Is this the product you have?

  • Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only
  • MFGArrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta
  • NDC54569-6488-0
Lot codes and dates
  • Expiry
  • lot
    • 1/31/2019: 7293219
    • 6/30/2019: 7362231
    • 8074161
    • 8110184
    • 8197215
    • 8114178
    • 8115123
    • 9/30/2018: 7132187
    • 7160161
    • 7180150
    • 7268239
Amount recalled
531 bottles

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.