Cardioplegia Solution — Class II drug recall D-0673-2023
Terminated recall by Central Admixture Pharmacy Services, Inc., reported 2023-05-31, distributed nationwide. Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products int
| Recall number | D-0673-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Central Admixture Pharmacy Services, Inc., Allentown, PA, United States |
| Recall initiated | 2023-04-28 |
| Classified | 2023-05-19 |
| Reported by FDA | 2023-05-31 |
| Terminated | 2025-06-22 |
| Distributed | Nationwide (US) |
| Quantity | 329 bags |
| Reason classes | sterility |
| NDC | 71285-0209-01 |
| Lot numbers | 37-893789, 37-894318, 37-895648, 37-897301, 37-898815 |
| Expiration dates | 2023-04-28, 2023-04-29, 2023-05-05, 2023-05-12, 2023-05-18 |
Product
Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
Reason for recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0673-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.