Recalls / Class II
Class IID-1265-2022
Product
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50
- Affected lot / code info
- Lots: MS2002A, Exp. 7/2/2022; MS2003A, Exp. 7/30/2022; MS2005A, Exp. 7/31/2022; MS2008A, Exp. 8/23/2022; MS2013A, Exp. 9/9/2022; MS2015A, Exp. 9/26/2022; MS2019A, Exp. 10/14/2022
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 5495 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-30
- FDA classified
- 2022-07-18
- Posted by FDA
- 2022-07-27
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1265-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.