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.
Recall Number: D-1486-2014
Firm: Boehringer Ingelheim Roxane Inc
Classification: Class III
Status: Terminated
Report Date: 20140806
Initiation Date: 20140728
Termination Date: 20150529
Reason for Recall
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Product Description
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.