Reported Aug 29, 2018 · Ongoing

Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang…

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
    • 80 MG
    • 30-count bottle (NDC 54569-6582-0
    • 90-count bottle (NDC 54569-6582-1)
    • Rx Only
  • MFGZhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
Lot codes and dates
  • Expiry
  • lot
    • [30-count] 11/30/2018: 7258177
    • 7276228
    • 2/28/2019: 7212260
    • [90-count] 11/30/2018: 7208140
    • 2/28/2019: 7212261
    • 7221155
    • 7222161
    • 8/31/2019: 8109171
    • 9/30/2019: 8109170
Amount recalled
178 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, 7:17 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.