FDA Drug recall D-0658-2023
Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 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, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 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-0658-2023 |
| 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, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1.
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 # 37-894304, Exp 04/29/2023; 37-894946, Exp 05/01/2023; 37-896482, Exp 05/07/2023; 37-897933, Exp 05/13/2023; 37-900461, Exp 05/22/2023 |
|---|
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-0658-2023%22
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