CARDIOPLEGIA SOLUTION — Class II drug recall D-1109-2023
Terminated recall by Central Admixture Pharmacy Services, Inc., reported 2023-09-06, distributed nationwide. Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
| Recall number | D-1109-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Central Admixture Pharmacy Services, Inc., Phoenix, AZ, United States |
| Recall initiated | 2023-08-17 |
| Classified | 2023-08-28 |
| Reported by FDA | 2023-09-06 |
| Terminated | 2025-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 84 bags |
| Reason classes | sterility |
| NDC | 72196-0111-01 |
| Lot numbers | 36-262515 |
| Expiration dates | 2023-08-25 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1109-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.