D-1020-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 14, 2023
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 bags
Product Description
CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 36-254914, Exp. 7/22/2023.