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FDAJuly 14, 2023drug

Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarit...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

What to do

FDA enforcement status: Terminated

Brands named

central admixture pharmacy servicescentralcentral admixture

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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