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FDAApril 12, 2019drug

DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enterprise Pharmacy, 4...

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

The hazard

Lack of sterility assurance.

What to do

FDA enforcement status: Terminated

Brands named

cmc enterprise pharmacycmccmc enterprise

Recall history

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

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