FDA Drug recall D-0777-2023
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, ND…
- FDA Drug
- Class II
- terminated
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, ND… by Fresenius Medical Care Holdings, citing lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0777-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-05-23 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | NC, SC, VA |
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
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Identifiers
| ndc | 49230-300-10 |
|---|---|
| code_info | Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0777-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.