FDA recall D-1609-2014

Apotex Corp. · Class III · drug

Product

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03

Reason for recall

Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2014-04-18
Report date: 2014-10-01
Termination date: 2017-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1609-2014