FDA recall D-0151-2020
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center · Class II · drug
Product
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
Reason for recall
Lack of Assurance of Sterility; bags have potential to leak
Distribution
Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2019-10-09
- Report date
- 2019-10-30
- Termination date
- 2020-12-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- West Columbia, SC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2020