FDA Drug recall D-1123-2023
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc.,…
- FDA Drug
- Class II
- terminated
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc.,… by Central Admixture Pharmacy Services, citing lack of Assurance of Sterility:Lack of validation data for sanitization cycles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1123-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-08-17 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
Product
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Reason
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Identifiers
| code_info | Lot# 36-262542, Exp 8/25/2023 ; |
|---|
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-1123-2023%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.