FDA DrugsClass II
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distrib...
Published: April 15, 2026Recall ID: D-0448-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of particulate matter
Product Description & Identification
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
Additional Source Details
| Field | Value |
|---|---|
| City | Carrigtwohill |
| Openfda › Nui › 1 | N0000180185 |
| Openfda › Nui › 2 | N0000010258 |
| Openfda › Unii | 4419T9MX03 |
| Openfda › Route › 1 | INTRAVASCULAR |
| Openfda › Route › 2 | INTRAVENOUS |
| Openfda › Spl id | 61f3e388-89bf-43d6-ad51-b620fff561fb |
| Openfda › Brand name | OMNIPAQUE |
| Openfda › Spl set id | eee15ebe-d349-4497-acef-6abe7a8247fb |
| Openfda › Package ndc › 1 | 0407-1401-52 |
| Openfda › Package ndc › 2 | 0407-1411-10 |
| Openfda › Package ndc › 3 | 0407-1411-20 |
| Openfda › Package ndc › 4 | 0407-1412-10 |
| Openfda › Package ndc › 5 | 0407-1412-20 |
| Openfda › Package ndc › 6 | 0407-1412-50 |
| Openfda › Package ndc › 7 | 0407-1412-29 |
| Openfda › Package ndc › 8 | 0407-1412-30 |
| Openfda › Package ndc › 9 | 0407-1412-60 |
| Openfda › Package ndc › 10 | 0407-1412-33 |
| Openfda › Package ndc › 11 | 0407-1412-27 |
| Openfda › Package ndc › 12 | 0407-1412-49 |
| Openfda › Package ndc › 13 | 0407-1412-34 |
| Openfda › Package ndc › 14 | 0407-1412-28 |
| Openfda › Package ndc › 15 | 0407-1412-35 |
| Openfda › Package ndc › 16 | 0407-1413-11 |
| Openfda › Package ndc › 17 | 0407-1413-10 |
| Openfda › Package ndc › 18 | 0407-1413-59 |
| Openfda › Package ndc › 19 | 0407-1413-30 |
| Openfda › Package ndc › 20 | 0407-1413-50 |
| Openfda › Package ndc › 21 | 0407-1413-51 |
| Openfda › Package ndc › 22 | 0407-1413-61 |
| Openfda › Package ndc › 23 | 0407-1413-95 |
| Openfda › Package ndc › 24 | 0407-1413-98 |
| Openfda › Package ndc › 25 | 0407-1413-62 |
| Openfda › Package ndc › 26 | 0407-1413-99 |
| Openfda › Package ndc › 27 | 0407-1413-60 |
| Openfda › Package ndc › 28 | 0407-1413-63 |
| Openfda › Package ndc › 29 | 0407-1413-91 |
| Openfda › Package ndc › 30 | 0407-1413-53 |
| Openfda › Package ndc › 31 | 0407-1413-90 |
| Openfda › Package ndc › 32 | 0407-1413-65 |
| Openfda › Package ndc › 33 | 0407-1413-92 |
| Openfda › Package ndc › 34 | 0407-1413-66 |
| Openfda › Package ndc › 35 | 0407-1413-93 |
| Openfda › Package ndc › 36 | 0407-1413-96 |
| Openfda › Package ndc › 37 | 0407-1413-69 |
| Openfda › Package ndc › 38 | 0407-1414-21 |
| Openfda › Package ndc › 39 | 0407-1414-50 |
| Openfda › Package ndc › 40 | 0407-1414-51 |
| Openfda › Package ndc › 41 | 0407-1414-52 |
| Openfda › Package ndc › 42 | 0407-1414-89 |
| Openfda › Package ndc › 43 | 0407-1414-20 |
| Openfda › Package ndc › 44 | 0407-1414-90 |
| Openfda › Package ndc › 45 | 0407-1414-22 |
| Openfda › Package ndc › 46 | 0407-1414-53 |
| Openfda › Package ndc › 47 | 0407-1414-60 |
| Openfda › Package ndc › 48 | 0407-1414-91 |
| Openfda › Package ndc › 49 | 0407-1414-76 |
| Openfda › Package ndc › 50 | 0407-1414-03 |
| Openfda › Package ndc › 51 | 0407-1414-23 |
| Openfda › Package ndc › 52 | 0407-1414-93 |
| Openfda › Package ndc › 53 | 0407-1414-04 |
| Openfda › Package ndc › 54 | 0407-1414-94 |
| Openfda › Package ndc › 55 | 0407-1414-24 |
| Openfda › Package ndc › 56 | 0407-1414-80 |
| Openfda › Package ndc › 57 | 0407-1414-95 |
| Openfda › Package ndc › 58 | 0407-1415-09 |
| Openfda › Package ndc › 59 | 0407-1416-12 |
| Openfda › Product ndc › 1 | 0407-1401 |
| Openfda › Product ndc › 2 | 0407-1411 |
| Openfda › Product ndc › 3 | 0407-1412 |
| Openfda › Product ndc › 4 | 0407-1413 |
| Openfda › Product ndc › 5 | 0407-1414 |
| Openfda › Product ndc › 6 | 0407-1415 |
| Openfda › Product ndc › 7 | 0407-1416 |
| Openfda › Generic name | IOHEXOL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | IOHEXOL |
| Openfda › Pharm class epc | Radiographic Contrast Agent [EPC] |
| Openfda › Pharm class moa | X-Ray Contrast Activity [MoA] |
| Openfda › Manufacturer name | GE Healthcare Inc. |
| Openfda › Application number | NDA018956 |
| Openfda › Is original packager | true |
| Event id | 98656 |
| Address 1 | Ida Business Park |
| Code info | Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029 |
| Postal code | N/A |
| Report date | 20260415 |
| Product type | Drugs |
| Product quantity | 306,810 vials |
| Reason for recall | Presence of particulate matter |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Center classification date | 20260409 |
Overview
- Recalling FirmGE Healthcare Ireland Limited
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide.