D-0138-2020 Class III Terminated

Recalled by GUERBET LLC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
October 16, 2019
Initiation Date
September 13, 2019
Termination Date
October 25, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3140 syringes

Product Description

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 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.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: L159A, Exp. 06/2021; L169A, Exp. 07/2021