FDA recall D-002-2014

Product

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59

Reason for recall

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-03

Report date

2013-11-27

Termination date

2014-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-002-2014