Status
Terminated
Drug Enforcement D-1020-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Classification
Class II
Report Date
August 9, 2023
Termination Date
March 28, 2025
Product Information
- 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
- Product quantity
- 28 bags
- Reason for recall
- Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- 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-1020-2023
- Event ID
- 92707
- Recall initiation date
- July 14, 2023
- Center classification date
- August 1, 2023
- Code info
- Lot: 36-254914, Exp. 7/22/2023.
- More code info
- —