PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 30, 2019 Initiated: October 9, 2019 #D-0151-2020

Product Description

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

Details

Units Affected
1047 bags
Distribution
Nationwide.
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
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. Recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center. Units affected: 1047 bags.
Why was this product recalled?
Lack of Assurance of Sterility; bags have potential to leak
Which agency issued this recall?
This recall was issued by the FDA Drug on October 30, 2019. Severity: Moderate. Recall number: D-0151-2020.