FDA recall D-0367-2023

Product

Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Distribution

United States including Puerto Rico and Canada

Key facts

Status

Terminated

Initiation date

2023-02-07

Report date

2023-03-08

Termination date

2024-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0367-2023