Cardioplegia Solution del Nido Formula — Class II drug recall D-0956-2023
Terminated recall by Central Admixture Pharmacy Services, Inc., reported 2023-08-09, distributed nationwide. Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
| Recall number | D-0956-2023 |
|---|---|
| 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 | 2023-07-14 |
| Classified | 2023-08-01 |
| Reported by FDA | 2023-08-09 |
| Terminated | 2025-03-28 |
| Distributed | Nationwide (US) |
| Quantity | 10,480 bags |
| Reason classes | sterility |
| NDC | 72196-0202-01 |
| Lot numbers | 36-247605, 36-247608, 36-247609, 36-247610, 36-247819, 36-247820, 36-247821, 36-247822, 36-248139, 36-248142, 36-248143, 36-248144, 36-248303, 36-248304, 36-248305, 36-248306, 36-248316, 36-248509, 36-248511, 36-248513, 36-248514, 36-248815, 36-248816, 36-248817, 36-248818, 36-248962, 36-248964, 36-248966, 36-249216, 36-249220, 36-249222, 36-249575, 36-249576, 36-249577, 36-249631, 36-249632, 36-249836, 36-250033, 36-250034, 36-250035 and 54 more |
| Expiration dates | 2023-07-10, 2023-07-11, 2023-07-12, 2023-07-14, 2023-07-15, 2023-07-16, 2023-07-17, 2023-07-18, 2023-07-19, 2023-07-21, 2023-07-22, 2023-07-23, 2023-07-24, 2023-07-30, 2023-07-31, 2023-08-01, 2023-08-05, 2023-08-07, 2023-08-08, 2023-08-11, 2023-08-12, 2023-08-13, 2023-08-14 |
Product
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1
Reason for recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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-0956-2023. 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.