Drug recall D-0448-2026
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.
Reason for recall
Presence of particulate matter
Lots and codes
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
Recall details
- Recalling firm
- GE Healthcare Ireland Limited, Carrigtwohill
- Quantity
- 306,810 vials
- Distribution
- U.S. Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 24, 2026
Related products
- Omnipaque – drug information
- NDC 0407-1411 Omnipaque · Iohexol 180 mg/mL · GE Healthcare Inc.
- NDC 0407-1415 Omnipaque · Iohexol 9 mg/mL · GE Healthcare Inc.
- NDC 0407-1401 Omnipaque · Iohexol 140 mg/mL · GE Healthcare Inc.
- NDC 0407-1413 Omnipaque · Iohexol 300 mg/mL · GE Healthcare Inc.
- NDC 0407-1412 Omnipaque · Iohexol 240 mg/mL · GE Healthcare Inc.
- NDC 0407-1414 Omnipaque · Iohexol 350 mg/mL · GE Healthcare Inc.
- NDC 0407-1416 Omnipaque · Iohexol 12 mg/mL · GE Healthcare Inc.