FDA-Drug2019-10-30Class II

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

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Hazard

Lack of Assurance of Sterility; bags have potential to leak

Sold states
Nationwide.
Affected count
1047 bags
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0151-2020

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