Del Nido Cardioplegia Solution recalled over sterility concerns

Recall date

October 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th…

Recall number

D-0151-2020

FDA classification

Class II

Brand / firm

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Sold / distributed

Nationwide.

Why it was recalled

Lack of Assurance of Sterility; bags have potential to leak

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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