FDAFDA · Food and drugs·Recall number D-1240-2019
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.
Published May 1, 2019 · Recall initiated: April 12, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CMC Enterprise Pharmacy
- Distributor
- NC
- Lot
- Lots: ED041909 Exp. 4/13/2019; ED111907 Exp. 4/20/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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