Drug product
Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36
D-1447-2014
Product summary
- Event
- Event 64611
- Status
- Terminated
- Classification
- Class I
- Quantity
- 55/1 mL/20mg/mL syringe
- Official record key
drug-enforcement:D-1447-2014
Official wording
Reason: Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Code information: Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36
Distribution pattern: Product was shipped to the following states: CO, MA, OH, TX & WY.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix up