CMC Enterprise Pharmacy recalls 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
Recalled May 1, 2019 · FDA recall D-1240-2019 · CMC Enterprise Pharmacy
Hazard
Lack of sterility assurance. · FDA Class II
Units
110 bags
Sold at
NC
Description
Lack of sterility assurance.
Product
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, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Manufacturer(s)
CMC Enterprise Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →