FDA recall D-0114-2021

Product

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-11-18

Report date

2020-12-09

Termination date

2023-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0114-2021