NDC 0407-1412

Omnipaque 240 mg per 1 mL injection, solution

Where it's made

Factory	Where	Role	Last FDA inspection
GE Healthcare (Shanghai) Co Ltd.	China (Shanghai) Pilot Free Trade Zone, China	Makes it	Problems found, fixed voluntarilyOct 30, 2025 · 6 inspections
GE Healthcare AS	Oslo, Norway	Makes it	Problems found, fixed voluntarilyApr 23, 2024 · 8 inspections
GE Healthcare AS avd Lindesnes	Lindesnes, Norway	Makes the active ingredient	Problems found, fixed voluntarilyFeb 7, 2025 · 2 inspections
GE Healthcare Ireland Limited	Carrigtohill, Ireland	Makes it	Problems found, fixed voluntarilyNov 5, 2021 · 4 inspections

Mar 24, 2026 · Class II · GE Healthcare Ireland Limited
Presence of particulate matter
Lots: Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lo…
Mar 24, 2026 · Class II · GE Healthcare Ireland Limited
Presence of particulate matter
Lots: 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 Lo…
Oct 29, 2018 · Class II · GE Healthcare Inc. Life Sciences
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Lots: Lot #: 14301544, Exp 21Sep21

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Iohexol: every company that makes it
Form: injection, solution, intra-articular; intrathecal; intravascular; intravenous; oral; rectal
Strength: 240 mg per 1 mL
Approval: NDA NDA018956
On the market since: Dec 26, 1985
Package NDCs: 0407-1412-10 0407-1412-20 0407-1412-27 0407-1412-28 0407-1412-29 0407-1412-30 0407-1412-33 0407-1412-34 0407-1412-35 0407-1412-49 0407-1412-50 0407-1412-60
Official label: DailyMed (National Library of Medicine), updated Apr 7, 2026

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