D-1447-2014 Class I Terminated
FDA drug recall D-1447-2014 was initiated by Shamrock Medical Solutions Group LLC on Sep 27, 2011 and is designated Class I. Reason for recall: Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL The recall status is terminated (terminated Jul 31, 2014). Affected quantity: 55/1 mL/20mg/mL syringe.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 30, 2014
- Initiation Date
- Sep 27, 2011
- Termination Date
- Jul 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55/1 mL/20mg/mL syringe
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
Distribution Pattern
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