D-0649-2022 Class II Terminated

Recalled by The Harvard Drug Group — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
March 16, 2022
Initiation Date
February 28, 2022
Termination Date
June 8, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
174 cartons

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022