FDAFDA · Food and drugs·Recall number D-0956-2023
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, 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, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1
Published August 9, 2023 · Recall initiated: July 14, 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. Validation data for decontamination cycles is lacking.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot: 36-252365, 36-252368, 36-252369, 36-253887, 36-253888, Exp. 8/1/2023; 36-254404, 36-254406, 36-254407, 36-254408, 36-254409, 36-254410, Exp. 8/5/2023; 36-255219, 36-255220, 36-255221, 36-255222, 36-255223, Exp. 8/7/2023; 36-255420, 36-255421, 36-255422, 36-255424, 36-255425, 36-255453, 36-255454, 36-255731, Exp. 8/8/2023; 36-247605, 36-247608, 36-247609, 36-247610, Exp. 7/10/2023; 36-255880, 36-255881, 36-255882, 36-255883, 36-255884, 36-255885, 36-255887, 36-256004, Exp. 8/11/2023; 36-247819, 36-247820, 36-247821, 36-247822, Exp. 7/11/2023; 36-256108, 36-256109, 36-256110, 36-256111, 36-256112, 36-256113, Exp. 8/12/2023; 36-248139, 36-248142, 36-248143, 36-248144, Exp. 7/12/2023; 36-256326, 36-256327, 36-256328, 36-256329, 36-256330, 36-256331, Exp 8/13/2023; 36-256701, 36-257025, Exp. 8/14/2023; 36-248303, 36-248304, 36-248305, 36-248306, 36-248316, Exp. 7/14/2023; 36-248509, 36-248511, 36-248513, 36-248514, Exp. 7/15/2023; 36-248815, 36-248816, 36-248817, 36-248818, Exp. 7/16/2023; 36-248962, 36-248964, 36-248966, Exp. 7/17/2023; 36-249216, 36-249220, 36-249222, Exp. 7/18/2023; 36-249575, 36-249576, 36-249577, Exp. 7/19/2023; 36-249631, 36-249632, Exp. 7/21/2023; 36-249836, Exp. 7/22/2023; 36-250033, 36-250034, 36-250035, Exp. 7/23/2023; 36-250388, 36-250391, Exp. 7/24/2023; 36-251697, 36-251699, 36-251700, Exp. 7/30/2023; 36-252078, 36-252079, 36-252080, Exp. 7/31/2023.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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