FDA recall D-1399-2012

Watson Laboratories Inc · Class III · drug

Product

Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.

Reason for recall

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2012-04-17
Report date
2012-07-11
Termination date
2013-03-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1399-2012