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.
USOptiray 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.
Recalling Firm: Liebel-Flarsheim Company LLC
Reason for Recall / Hazard
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Raleigh |
| State | NC |
| Openfda › Nui › 1 | N0000180185 |
| Openfda › Nui › 2 | N0000010258 |
| Openfda › Upc › 1 | 0300191332653 |
| Openfda › Upc › 2 | 0300191323651 |
| Openfda › Upc › 3 | 0300191333650 |
| Openfda › Unii | N3RIB7X24K |
| Openfda › Route › 1 | INTRA-ARTERIAL |
| Openfda › Route › 2 | INTRAVENOUS |
| Openfda › Spl id | 471b778f-d9cc-ff10-e063-6394a90a27c9 |
| Openfda › Brand name | OPTIRAY |
| Openfda › Spl set id | cd718d1c-f813-4114-a50d-c744ff7eb1bf |
| Openfda › Package ndc › 1 | 0019-1333-65 |
| Openfda › Package ndc › 2 | 0019-1323-65 |
| Openfda › Package ndc › 3 | 0019-1332-65 |
| Openfda › Product ndc › 1 | 0019-1323 |
| Openfda › Product ndc › 2 | 0019-1333 |
| Openfda › Product ndc › 3 | 0019-1332 |
| Openfda › Generic name | IOVERSOL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | IOVERSOL |
| Openfda › Pharm class epc | Radiographic Contrast Agent [EPC] |
| Openfda › Pharm class moa | X-Ray Contrast Activity [MoA] |
| Openfda › Manufacturer name | Liebel-Flarsheim Company LLC |
| Openfda › Application number | NDA020923 |
| Openfda › Is original packager | true |
| Event id | 99510 |
| Address 1 | 8800 Durant Rd |
| Code info | Lot # 25ZF3670, Exp Date: May 31, 2027. |
| Postal code | 27616-3104 |
| Report date | 20260819 |
| Product type | Drugs |
| Product quantity | 3,486 500mL-vials |
| Reason for recall | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260731 |
| Initial firm notification | |
| Center classification date | 20260819 |
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Overview
- Recalling FirmLiebel-Flarsheim Company LLC
- StatusOngoing
- Risk LevelClass I
- DistributionDistributed Nationwide in the US and Mexico.
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🚨 SAFETY ALERT: Liebel-Flarsheim Company LLC - 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. Check if your household is affected: https://therecallfile.com/recalls/optiray-imaging-bulk-package-350-ioversol-injection-74-350-mg-ml-organ/FDA-D-0773-2026
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