FDA recall D-1447-2014

Shamrock Medical Solutions Group LLC · Class I · 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

Reason for recall

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Distribution

Product was shipped to the following states: CO, MA, OH, TX & WY.

Key facts

Status: Terminated
Initiation date: 2011-09-27
Report date: 2014-07-30
Termination date: 2014-07-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lewis Center, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1447-2014