Reported Mar 16, 2022 · Terminated

PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by:…

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 · 17187 N Laurel Park Dr Ste 300 · Livonia, MI · 48152-2600

Is this the product you have?

  • PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only
  • Manufactured bySun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India
  • Distributed by
    • MAJOR PHARMACEUTICALS
    • 17177 N. Laurel Park Dr
    • Suite 233
    • Livonia
    • MI 48152
  • NDC0904-6937-61
Lot codes and dates
    • Lot #: N00522
    • Exp. Date 09/2022
    • N00618
    • Exp. Date 11/2022
Amount recalled
174 cartons

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications

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 Jun 8, 2023 · Data as of Sep 19, 5:54 PM UTC

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