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.
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