Recalls / Class II
Class IID-1110-2023
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
- Affected lot / code info
- Lot# 36-262516, Exp 8/25/2023.
Why it was recalled
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 84 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-17
- FDA classified
- 2023-08-28
- Posted by FDA
- 2023-09-06
- Terminated
- 2025-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1110-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.