FDA recall D-0649-2022

The Harvard Drug Group · Class II · drug

Product

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

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2022-02-28
Report date: 2022-03-16
Termination date: 2023-06-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2022