FDA Drug recall D-0138-2020
Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx…
- FDA Drug
- Class III
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class III recall of Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx… by Guerbet, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0138-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-09-13 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Guerbet |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| ndc | 0019-1188-81 |
|---|---|
| ndc | 0019-1188-27 |
| code_info | Lots: L159A, Exp. 06/2021; L169A, Exp. 07/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0138-2020%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.