CLASS II Drug recall · Reported 25 Mar 2020 · FDA Enforcement Report
Sodium Chloride 0.9% Injection recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling Sodium Chloride 0.9% Injection, USP, distributed nationwide in the US. The recall was initiated on 5 Mar 2020 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-1064-2020
- FDA event ID
- 85228
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2020
- FDA classified
- 26 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Mar 2020 | Recall initiated by company | |
| 25 Mar 2020 | Published in enforcement report | +20 days |
| 26 Mar 2020 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
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, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Which lots are affected?
Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020
Where was it sold?
Product was distributed throughout the United States.
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 |