FDA Drug recall D-0666-2023
Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharm…
- FDA Drug
- Class II
- terminated
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharm… 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-0666-2023 |
| 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, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.
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 # 37-894299, Exp 04/29/2023; 37-897051, Exp 05/11/2023; 37-897368, Exp 05/12/2023; 37-898794, Exp 05/18/2023; 37-89…Lot # 37-894299, Exp 04/29/2023; 37-897051, Exp 05/11/2023; 37-897368, Exp 05/12/2023; 37-898794, Exp 05/18/2023; 37-899614, Exp 05/20/2023; 37-900608, 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-0666-2023%22
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