Optiray Injection
FDA Recall NDC 0019-1333
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Optiray (NDC 0019-1333). A significant event, classified as Class II, was initiated on Sep 13, 2019 by Liebel-flarsheim Company Llc. The reported reason for this action was: "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 specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Sep 13, 2019
Oct 16, 2019
3860 syringes
Recall Profile & Regulatory Data
Event ID
83798
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
GUERBET LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 25, 2021
Product Description
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 Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00.
Batch or Lot Expiration Information
Lot# Lots: L141C, L162A Exp. 06/2021; L146DS, Exp. 05/2021
Affected Packages Involved in this Recall
0019-1333-06Product
0019-1333-11Product
0019-1333-16Product
0019-1333-21Product
0019-1333-75Product
0019-1333-77Product
0019-1333-91Product
0019-1333-83Product
0019-1333-81Product
0019-1333-78Product
0019-1333-52Product
0019-1333-95Product
0019-1333-90Product
0019-1333-87Product
0019-1333-55Product
0019-1333-85Product
0019-1333-00Product
0019-1333-27Product
0019-1323-06Product
0019-1323-11Product
0019-1323-16Product
0019-1323-21Product
0019-1323-73Product
0019-1323-75Product
0019-1323-77Product
0019-1323-91Product
0019-1323-83Product
0019-1323-81Product
0019-1323-70Product
0019-1323-78Product
0019-1323-52Product
0019-1323-95Product
0019-1323-90Product
0019-1323-87Product
0019-1323-55Product
0019-1323-85Product
0019-1323-00Product
0019-1323-27Product
0019-1323-02Product
0019-1323-04Product
0019-1332-06Product
0019-1332-11Product
0019-1332-16Product
0019-1332-21Product
0019-1332-75Product
0019-1332-78Product
0019-1332-91Product
0019-1332-83Product
0019-1332-90Product
0019-1332-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
