October 2018 FDA Recall Omnipaque by Ge Healthcare Inc. Life Sciences
D-0319-2019 - Defective Container
This Class II drug recall was voluntarily initiated by Ge Healthcare Inc. Life Sciences on October 29, 2018 for the product Omnipaque. The FDA reported the reason for recall as defective container. The product was distributed in TN and the recall is currently terminated.
Recall Number: D-0319-2019
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.
10-29-2018
12-26-2018
1092 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
GE Healthcare Inc. Life Sciences
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TN
10-30-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# : 14301544, Exp 21Sep21
