FDAFDA · Food and drugs·Recall number D-1112-2023
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1
Published September 6, 2023 · Recall initiated: August 17, 2023
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 Assurance of Sterility:Lack of validation data for sanitization cycles
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot# 36-260068, 36-260062, 36-260070, 36-260063, 36-260064, Exp 8/29/2023; 36-260016, Exp 9/3/2023; 36-262540, 36-262536, 36-262534, Exp 9/9/2023; 36-262990, 36-262992, Exp 9/12/2023. ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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