Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 14301544, Exp 21Sep21
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE Healthcare Inc. Life Sciences
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20.
Product Codes/Lot Numbers:
Lot #: 14301544, Exp 21Sep21
Distribution:
Distributed in: TN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0319-2019