Drug Enforcement D-0956-2023

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

Status

Terminated

Classification

Class II

Report Date

August 9, 2023

Termination Date

March 28, 2025

Product Information

Product description
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
Product quantity
10,480 bags
Reason for recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Central Admixture Pharmacy Services, Inc.
Address
2200 S 43rd Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0956-2023
Event ID
92707
Recall initiation date
July 14, 2023
Center classification date
August 1, 2023
Code info
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.
More code info
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