Reported Dec 9, 2020 · Terminated

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto,…

The Harvard Drug Group

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: The Harvard Drug Group · 17177 N Laurel Park Dr Ste 233 · Livonia, MI · 48152-3951

Is this the product you have?

  • Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only
  • Manufactured byApotex, Inc, Toronto, Ontario Canada M9L 1T9
  • Distributed by
    • Major Pharmaceuticals
    • 17177 N. Laurel Park Dr
    • Suite 233
    • Livonia
    • MI 48152 USA
    • NDC 0904-6512-04
Lot codes and dates
  • Lots
    • T02520
    • T02637
    • exp 02/2021
Amount recalled
841 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Out of specification for dissolution.

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 Feb 19, 2023 · Data as of Sep 19, 8:09 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.