FDA-Drug2014-08-06Class III
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.
Boehringer Ingelheim Roxane Inc
Hazard
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Sold states
U.S. Nationwide
Affected count
2,149 Bottles
Manufactured in
1809 Wilson Rd, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1486-2014Don't want to check this manually?
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