D-1109-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 6, 2023
- Initiation Date
- August 17, 2023
- Termination Date
- March 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 bags
Product 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
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 36-262515, Exp 8/25/2023.