FDA recall D-0692-2017

The Harvard Drug Group · Class III · drug

Product

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04

Reason for recall

Superpotent Drug; out of specification results for assay (manufacturer)

Distribution

Nationwide and PR

Key facts

Status: Terminated
Initiation date: 2016-12-27
Report date: 2017-05-10
Termination date: 2017-07-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0692-2017