FDA-Drug2022-07-27Class II

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

Nephron Sterile Compounding Center LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
1765 bags
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1269-2022

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