Why it was recalled
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
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
Lot numbers, UPCs & expiration codes
Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36
Where it was sold
Product was shipped to the following states: CO, MA, OH, TX & WY.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1447-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 27, 2011
- FDA report date
- Jul 30, 2014
- Quantity
- 55/1 mL/20mg/mL syringe
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shamrock Medical Solutions Group LLC
Original FDA data
Every field from FDA enforcement report D-1447-2014, exactly as published.
Show all FDA fields
- City
- Lewis Center
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 64611
- Address
- 741 Radio Dr
- Code information
- Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36
- Postal code
- 43035-7134
- Report date
- Jul 30, 2014
- Product type
- Drugs
- Recall number
- D-1447-2014
- Classification
- Class I
- Recalling firm
- Shamrock Medical Solutions Group LLC
- Product quantity
- 55/1 mL/20mg/mL syringe
- Termination date
- Jul 31, 2014
- Reason for recall
- Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Recall initiation date
- Sep 27, 2011
- Initial firm notification
- Telephone
- Center classification date
- Jul 23, 2014