FDA-Drug2019-10-16Class III

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.

GUERBET LLC
Hazard

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.

Sold states
Nationwide in the USA
Affected count
3140 syringes
Manufactured in
821 Alexander Rd, Ste 204, 120 W 7th St Suite, Princeton, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0138-2020

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