Princeton, NJ, United States
GUERBET LLC recalls
1 recall recorded since 2018, most recently on 13 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II, Class III Drugs
- Recall started
- 13 September 2019
- Terminated
- 25 October 2021
- 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.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0138-2020, D-0137-2020
- 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 001
- Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Com
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.