Drug 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.
D-1486-2014
Product summary
- Event
- Event 68879
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,149 Bottles
- Official record key
drug-enforcement:D-1486-2014
Official wording
Reason: Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Code information: Lot #: 360241A, Expiry: 05/2015.
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification