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…

Recall date

April 12, 2019

Source

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

Recall number

D-1240-2019

FDA classification

Class II

Brand / firm

CMC Enterprise Pharmacy

Sold / distributed

NC

Why it was recalled

Lack of sterility assurance.

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

What was recalled

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.