Drug product
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
D-1441-2016
Product summary
- Event
- Event 74253
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,182 bottles
- Official record key
drug-enforcement:D-1441-2016
Official wording
Reason: Failed Impurities/Degradation Specification; 9 month stability
Code information: Lot #560185A; Exp. 6/30/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specification