CLASS II Drug recall · Reported 7 Jun 2023 · FDA Enforcement Report
Sodium Chloride 0.9% Injection, USP bags recalled
Fresenius Medical Care Holdings is recalling Sodium Chloride 0.9% Injection, USP bags per, distributed in North Carolina, South Carolina, Virginia. The recall was initiated on 23 May 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0777-2023
- FDA event ID
- 92403
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Brand
- Sodium Chloride
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 May 2023
- FDA classified
- 1 Jun 2023
- Reported
- 7 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 23 May 2023 | Recall initiated by company | |
| 1 Jun 2023 | Classified by FDA | +9 days |
| 7 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to 32 clinics in SC, NC and VA.
Questions about this recall
Why was it recalled?
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Which lots are affected?
Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024
Where was it sold?
Product was distributed to 32 clinics in SC, NC and VA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sodium Chloride recalls
All 132| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | 0.9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride | Huons | Sterility | Nationwide |