Liebel-Flarsheim Company LLC Optiray Imaging Bulk Package-350 Recall
Recall covers Lot # 25ZF3670 of Optiray Imaging Bulk Package-350 (Ioversol Injection 74%, 350 mg/mL) in a 500 mL multiple-dose vial, Rx only, sterile solution manufactured by Liebel-Flarsheim Company LLC. The recall is due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass. There are 3,486 vials distributed nationwide in the US and Mexico with an expiration date of May 31, 2027; no corrective action information is provided in the record.
| Brand | Liebel-Flarsheim Company LLC |
|---|---|
| Product | Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65. |
| Reason | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. |
| Severity | critical |
| Units affected | 3486 |
| Distribution | Distributed Nationwide in the US and Mexico. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any remaining vials from Lot 25ZF3670.
- Contact your healthcare provider or supplier to arrange disposal or return of the product or to obtain a replacement.
- If you have used the product and have concerns or experience symptoms, contact your clinician and report adverse events to the FDA MedWatch program.
- Stay tuned for recall updates from the FDA and the manufacturer.
How to identify the recalled item
| Lot / date codes | Lot # 25ZF3670, Exp Date: May 31, 2027. |
|---|---|
| Lot / date codes | Lot # 25ZF3670, Exp Date: May 31, 2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.