Reported Oct 16, 2019 · Terminated
Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton,…
Guerbet LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GUERBET LLC · 821 Alexander Rd, Ste 204 · Princeton, NJ · 08540-0000
Is this the product you have?
- Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only
- Manufactured byLiebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1188-27
- Lot codes and dates
- Lots
L159AExp. 06/2021L169AExp. 07/2021
- Lots
- Amount recalled
- 3140 syringes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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