Reported Dec 26, 2018 · Terminated
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only,…
GE Healthcare Inc. Life Sciences
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare Inc. Life Sciences · 100 Results Way · Marlborough, MA · 01752-3078
Is this the product you have?
- 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 codes and dates
Lot #: 14301544Exp 21Sep21
- Amount recalled
- 1092 cartons
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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