Reported Aug 7, 2019 · Terminated

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by…

Major Pharmaceuticals

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: MAJOR PHARMACEUTICALS · 17177 N Laurel Park Dr · Livonia, MI · 48152-2693

Is this the product you have?

  • DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India
  • Distributed by
    • Major Pharmaceuticals 17177 N Laurel Park Dr
    • Suite 233 Livonia
    • MI 48152. NDC # 0904-6363-61
Lot codes and dates
  • Lot# M02250 EXP 10/2020.
Amount recalled
828 100-count unit dose cartons

Where it was sold

  • Nationwide

Why it was recalled

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

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

Notice updated Jul 16, 2020 · Data as of Sep 19, 3:34 PM UTC

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