Drug product
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
D-0838-2016
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 73909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,901 cases
- Official record key
drug-enforcement:D-0838-2016
Official wording
Reason: Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Code information: Lot # 435200, EXP 01/18
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.