Product Safety Recalls

Product Recall Tracker

Recall D-1109-2023

Description: CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1

Recall D-1109-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1109-2023
Event ID92898
DistributionNationwide in the USA
Quantity84 bags
Recall ReasonLack of Assurance of Sterility:Lack of validation data for sanitization cycles
Drug ClassificationClass II
Drug Code Info20230906
Recall Initiation Date20230817
Report Date20230906
Classification Date20230828
Address2200 S 43rd Ave
Phoenix, AZ 85043-3909
United States
Recalling FirmCentral Admixture Pharmacy Services, Inc.
Initial Notification Letter
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