Why it was recalled
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.
Product 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.
Lot numbers, UPCs & expiration codes
Lot #: 14301544, Exp 21Sep21
Where it was sold
TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0319-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 29, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 1092 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GE Healthcare Inc. Life Sciences
Original FDA data
Every field from FDA enforcement report D-0319-2019, exactly as published.
Show all FDA fields
- City
- Marlborough
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 81691
- Address
- 100 Results Way
- Code information
- Lot #: 14301544, Exp 21Sep21
- Postal code
- 01752-3078
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0319-2019
- Classification
- Class II
- Recalling firm
- GE Healthcare Inc. Life Sciences
- Product quantity
- 1092 cartons
- Termination date
- Oct 30, 2023
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- TN
- Recall initiation date
- Oct 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 14, 2018