Skip to content
Recall Observatory FDA recall evidence

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

September 27, 2011

Class I

Product summary

Firm
Shamrock Medical Solutions Group LLC
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

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix up