PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx o...
FDA Recall #D-0649-2022 — Class II — February 28, 2022
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
The Harvard Drug Group — Livonia, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
174 cartons
Distribution
Nationwide within the United States
Code Information
Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated