Drug product
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
D-1111-2023
Product summary
- Event
- Event 92898
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 bags
- Official record key
drug-enforcement:D-1111-2023
Official wording
Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Code information: Lot# 36-262881, Exp 8/27/2023.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility