FDA recall D-1079-2015

Apotex Inc. · Class III · drug

Product

Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

Reason for recall

Subpotent drug

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-04-07
Report date: 2015-05-20
Termination date: 2017-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1079-2015