FDA Drug recall D-1030-2023
CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pha…
- FDA Drug
- Class II
- terminated
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pha… by Central Admixture Pharmacy Services, citing lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1030-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-14 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
Product
CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
Reason
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Identifiers
| code_info | Lot:36-256332, Exp. 7/29/2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1030-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.