PlainRecalls
FDA Drug Moderate Class II Terminated

del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10

Reported: July 27, 2022 Initiated: June 30, 2022 #D-1269-2022

Product Description

del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, 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

Details

Units Affected
1765 bags
Distribution
Nationwide in the USA
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10. Recalled by Nephron Sterile Compounding Center LLC. Units affected: 1765 bags.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on July 27, 2022. Severity: Moderate. Recall number: D-1269-2022.