FDA recall D-1486-2014

Product

OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.

Reason for recall

Failed Stability Specifications: Out of specification result for preservative sodium benzoate.

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-28

Report date

2014-08-06

Termination date

2015-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1486-2014