GE Healthcare Omnipaque iohexol injection recalled for particulate matter contamination
GE Healthcare discovered particles in certain vials of Omnipaque (iohexol), a contrast dye used during medical imaging procedures. The contamination affects 11 specific lot numbers distributed nationwide. No injuries have been reported so far.
From the FDA notice · Read the official notice ↗ · All GE Healthcare recalls
What to do
- If you have any of the affected lot numbers, stop using them and contact your healthcare provider or pharmacy
- Check the lot number and expiration date on your vials against the list provided by GE Healthcare
- Contact GE Healthcare or the FDA if you have questions about affected lots
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 306,810 vials
- Illnesses reported
- None reported
- Manufactured in
- Ida Business Park, Carrigtwohill, Ireland
- Classification
- Class II
- Recall number
- D-0448-2026
In the FDA's words
- Description
- 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. Presence of particulate matter 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 Distribution: U.S. Nationwide. Affected quantity: 306,810 vials
- Hazard
- Presence of particulate matter
2 products in this recall
The agency lists each product separately. Check every one you might have.
- GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.D-0447-2026 · 866,570 vials
- 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. (this page)D-0448-2026 · 306,810 vials