CLASS II Drug recall · Reported 16 Jun 2021 · FDA Enforcement Report
Sodium Chloride recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling Sodium Chloride 0.9%, USP, distributed nationwide in the US. The recall was initiated on 28 Apr 2021 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-0603-2021
- FDA event ID
- 87907
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Apr 2021
- FDA classified
- 9 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Apr 2021 | Recall initiated by company | |
| 9 Jun 2021 | Classified by FDA | +42 days |
| 16 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Temperature Abuse: Product exposed to temperature outside specified limits.
Which lots are affected?
Lot #: 20NG02095, Exp. Date October 2021
Where was it sold?
Nationwide within 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.
Other products in this recall event
7 other products · FDA event 87907| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Delfelx Peritoneal Dialysis Solution with 4.25% Dextrose recalled | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 4.25% Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 2.5 % Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 2.5% Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalled | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide |
More recalls from Fresenius Medical Care Holdings
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5008X Blood Tubing Set recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide |
| Device | CLASS II | Bicarby" Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |
| Device | CLASS II | Bicarby Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | TX |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
Other Sodium Chloride recalls
All 133| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| 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 |