CLASS III Drug recall · Reported 16 Oct 2019 · FDA Enforcement Report
Sodium Chloride Injection recalled by Guerbet
Guerbet is recalling Sodium Chloride Injection USP 9%, distributed nationwide in the US. The recall was initiated on 13 Sep 2019 and the FDA has classified it as Class III.
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-0138-2020
- FDA event ID
- 83798
- Recalling firm
- Guerbet, Princeton, NJ
- Brand
- Sodium Chloride
- Manufacturer
- Liebel-Flarsheim Company LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Sep 2019
- FDA classified
- 9 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Sep 2019 | Recall initiated by company | |
| 9 Oct 2019 | Classified by FDA | +26 days |
| 16 Oct 2019 | 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
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1188-27.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Sodium Chloride Injection USP 9% recalled?
Yes. Guerbet recalled Sodium Chloride Injection USP 9% on 13 Sep 2019. The recall is Class III and its status is Terminated. Recall number D-0138-2020.
Why was it recalled?
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Which lots are affected?
Lots: L159A, Exp. 06/2021; L169A, Exp. 07/2021
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Guerbet
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Optiray 320 (ioversol) Injection recalled by GuerbetOptiray | Guerbet | Packaging Defects | Nationwide |
Other Sodium Chloride recalls
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 9% Sodium Chloride Injection USP, Viaflex recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP Ampules recalled by Huons CoSodium Chloride | Huons Co | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP 900 mg recalled by Fresenius Kabi USASodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP, 900 mg recalled by Fresenius Kabi USASodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 9% Sodium Chloride Injection, USP x60, Becton, Dickson recalledSodium Chloride | Fresenius Kabi USA | Sterility | Nationwide |