Reported Aug 29, 2018 · Ongoing

Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG:…

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 Tablets
    • 160 MG
    • 30-count bottle (NDC 54569-6583-0)
    • 90-count bottle (NDC 54569-6583-1)
    • Rx Only
  • MFGZhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
Lot codes and dates
  • Expiry
  • lot
    • [30-count] 2/28/2019: 7285177
    • 3/31/2019: 7222163
    • 7227175
    • 8/31/2019: 8162190
    • 8183227. [90-count] 2/28/2019: 7207135
    • 7212280
    • 7215073
    • 3/31/2019: 7222162
    • 8/31/2019: 8095248
    • 8095249
Amount recalled
666 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.

Want the full recall guide?

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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, 7:17 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.