Marlborough, MA, United States
GE Healthcare Inc. Life Sciences recalls
1 recall recorded since 2018, most recently on 29 October 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 29 October 2018
- Terminated
- 30 October 2023
- Reason
- 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.
- Distribution
- TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0319-2019
- 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,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.