FDA Drug recall D-0650-2023
Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh…
- FDA Drug
- Class II
- terminated
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh… 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-0650-2023 |
| 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, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.
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 # 37-893790, Exp 04/28/2023; 37-896488, Exp 05/07/2023; 37-898250, Exp 05/14/2023; 37-899235, Exp 05/19/2023; 37-900609, 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-0650-2023%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.