Recall D-1022-2023
Description: CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1
Recall D-1022-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1022-2023 |
Event ID | 92707 |
Distribution | Nationwide in the USA |
Quantity | 80 bags |
Recall Reason | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. |
Drug Classification | Class II |
Drug Code Info | 20230809 |
Recall Initiation Date | 20230714 |
Report Date | 20230809 |
Classification Date | 20230801 |
Address | 2200 S 43rd Ave Phoenix, AZ 85043-3909 United States |
Recalling Firm | Central Admixture Pharmacy Services, Inc. |
Initial Notification | Letter |
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