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FDAFDA · Alimentos y medicamentos·N.º oficial 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

Publicado el 9 de agosto de 2023 · Inicio del retiro: 14 de julio de 2023

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Central Admixture Pharmacy Services, Inc.
Distribuidor
Nationwide in the USA
Lote
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.
Clasificación de riesgo
Class II
Área (FDA)
drug
País
United States

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