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
Reported: July 30, 2014 Initiated: September 27, 2011 #D-1447-2014
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
Details
- Recalling Firm
- Shamrock Medical Solutions Group LLC
- Units Affected
- 55/1 mL/20mg/mL syringe
- Distribution
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Location
- Lewis Center, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Shamrock Medical Solutions Group LLC. Units affected: 55/1 mL/20mg/mL syringe.
Why was this product recalled? ▼
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 30, 2014. Severity: Critical. Recall number: D-1447-2014.
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