Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 m...
FDA Recall #D-1447-2014 — Class I — September 27, 2011
Product Description
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
Reason for Recall
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Recalling Firm
Shamrock Medical Solutions Group LLC — Lewis Center, OH
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
55/1 mL/20mg/mL syringe
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Code Information
Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated