Drug 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.
D-1240-2019
Product summary
- Event
- Event 82620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 bags
- Official record key
drug-enforcement:D-1240-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: ED041909 Exp. 4/13/2019; ED111907 Exp. 4/20/2019
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of sterility