0 — Class II drug recall D-0015-2023
Ongoing recall by Fresenius Medical Care Holdings, Inc., reported 2022-10-26, distributed nationwide. Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
| Recall number | D-0015-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2022-10-11 |
| Classified | 2022-10-20 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 16,006 cases |
| Reason classes | sterility, packaging |
| NDC | 49230-0300, 49230-0300-10 |
| Lot numbers | 22EU05043, 22HU05018, 22HU05019, 22HU05025, 22HU05026, 22HU05049, 22HU05053, 22HU05054, 22HU05055, 22HU06027, 22HU06049, 22HU06055, 22HU06056, 22JU05008, 22JU06023, 22KU06036 |
| Expiration dates | 2023-05-21, 2023-06-09, 2023-06-10, 2023-06-11, 2023-06-12, 2023-06-22, 2023-06-23, 2023-06-24, 2023-06-25, 2023-07-04, 2023-07-08, 2023-08-19 |
Product
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Reason for recall
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
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-0015-2023. 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.