FDAFDA · Food and drugs·Recall number D-0649-2022
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun 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. NDC: 0904-6937-61
Published March 16, 2022 · Recall initiated: February 28, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PALIPERIDONE
- Manufacturer
- The Harvard Drug Group
- Distributor
- Nationwide within the United States
- Lot
- Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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