GUERBET LLC recalls Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton,…

Recall date

September 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0138-2020

FDA classification

Class III

Brand / firm

GUERBET LLC

Sold / distributed

Nationwide in the USA

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.