GE Healthcare Ireland Limited: GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- GE Healthcare Ireland Limited
- 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 / hazard
- Presence of particulate matter
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide.
- Recall initiated
- 2026-03-24
- 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
- Product quantity
- 306,810 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Carrigtwohill
- Country
- Ireland
- Event id
- 98656
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