Recalls / Class I
Class ID-1447-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36
Why it was recalled
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Recalling firm
- Firm
- Shamrock Medical Solutions Group LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 741 Radio Dr, Lewis Center, Ohio 43035-7134
Distribution
- Quantity
- 55/1 mL/20mg/mL syringe
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
Timeline
- Recall initiated
- 2011-09-27
- FDA classified
- 2014-07-23
- Posted by FDA
- 2014-07-30
- Terminated
- 2014-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1447-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.