CLASS IIDrug recall · Reported 1 May 2019 · FDA Enforcement Report
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH recalled
CMC Enterprise Pharmacy is recalling DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 bag) Mannitol 20%, distributed in North Carolina. The recall was initiated on 12 Apr 2019 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLots: ED041909 Exp. 4/13/2019; ED111907 Exp. 4/20/2019
Quantity recalled110 bags
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.