FDA Drug recall D-0663-2023
Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, I…
- FDA Drug
- Class II
- terminated
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, I… by Central Admixture Pharmacy Services, citing lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0663-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-04-28 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Central Admixture Pharmacy Services |
| Distribution | US |
Product
Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1.
Reason
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Identifiers
| code_info | Lot # 37-893846, Exp 04/28/2023; 37-895704, Exp 05/05/2023; 37-897079, Exp 05/11/2023; 37-897927, Exp 05/13/2023; 37-89…Lot # 37-893846, Exp 04/28/2023; 37-895704, Exp 05/05/2023; 37-897079, Exp 05/11/2023; 37-897927, Exp 05/13/2023; 37-898814, Exp 05/18/2023; 37-900617, Exp 05/25/2023 |
|---|
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-0663-2023%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.