FDA Recall D-1447-2014
Shamrock Medical Solutions Group LLC · Lewis Center, OH
Class I — life-threatening Terminated 1038 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-1447-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Recall initiated
- 2011-09-27
- Classified by FDA Center
- 2014-07-23
- FDA published
- 2014-07-30
- Terminated
- 2014-07-31
- Recalling firm
- Shamrock Medical Solutions Group LLC
- Firm location
- Lewis Center, OH