Could cause temporary or reversible harm; serious harm is unlikely.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
| Distributed by / for | Central Admixture Pharmacy Services, Inc. |
| NDC | 72196-0202-1 |
| Full product label | 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 |
| Recalling firm | Central Admixture Pharmacy Services, Inc. |
| Distribution | Nationwide in the USA |
| Quantity | 10,480 bags |
| Recall initiated | 2023-07-14 |
| Report date | 2023-08-09 |
| Recall completed | 2025-03-28 |
| Recall number | D-0956-2023 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Phoenix AZ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗