Status
Terminated
Drug Enforcement D-1109-2023
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Classification
Class II
Report Date
September 6, 2023
Termination Date
March 27, 2025
Product Information
- 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
- Product quantity
- 84 bags
- Reason for recall
- Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Address
-
2200 S 43rd Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1109-2023
- Event ID
- 92898
- Recall initiation date
- August 17, 2023
- Center classification date
- August 28, 2023
- Code info
- Lot# 36-262515, Exp 8/25/2023.
- More code info
- —