Sodium Chloride 0 — Class II drug recall D-0777-2023
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2023-06-07, distributed in NC, SC, VA. Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures,
| Recall number | D-0777-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2023-05-23 |
| Classified | 2023-06-01 |
| Reported by FDA | 2023-06-07 |
| Terminated | 2024-05-23 |
| Distributed | NC, SC, VA |
| Quantity | 53,424 bags |
| Reason classes | sterility, packaging |
| NDC | 49230-0300, 49230-0300-10 |
| Lot numbers | 23AU05030, 23AU05035 |
| Expiration dates | 2024-01-13, 2024-01-15 |
Product
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Reason for recall
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
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-0777-2023. 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.