Boehringer Ingelheim Roxane Inc recalls OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratori
Recalled August 6, 2014 · FDA recall D-1486-2014 · Boehringer Ingelheim Roxane
Hazard
Failed Stability Specifications: Out of specification result for preservative sodium benzoate. · FDA Class III
Units
2,149 Bottles
Sold at
U.S. Nationwide
Description
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
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.
Manufacturer(s)
Boehringer Ingelheim Roxane Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →