Product Safety Recalls

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Recall D-1041-2023

Description: CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1

Recall D-1041-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1041-2023
Event ID92707
DistributionNationwide in the USA
Quantity104 bags
Recall ReasonLack of assurance of sterility. Validation data for decontamination cycles is lacking.
Drug ClassificationClass II
Drug Code Info20230809
Recall Initiation Date20230714
Report Date20230809
Classification Date20230801
Address2200 S 43rd Ave
Phoenix, AZ 85043-3909
United States
Recalling FirmCentral Admixture Pharmacy Services, Inc.
Initial Notification Letter
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