Omnipaque — Class II drug recall D-0319-2019
Terminated recall by GE Healthcare Inc. Life Sciences, reported 2018-12-26, distributed in TN. Defective Container: vial defect was identified that could potentially impact the container closure and result
| Recall number | D-0319-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare Inc. Life Sciences, Marlborough, MA, United States |
| Recall initiated | 2018-10-29 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2023-10-30 |
| Distributed | TN |
| Quantity | 1,092 cartons |
| Reason classes | foreign material, sterility, packaging |
| NDC | 00407-1401, 00407-1401-52, 00407-1411, 00407-1411-10, 00407-1411-20, 00407-1412, 00407-1412-10, 00407-1412-20, 00407-1412-27, 00407-1412-28, 00407-1412-29, 00407-1412-30, 00407-1412-33, 00407-1412-34, 00407-1412-35, 00407-1412-49, 00407-1412-50, 00407-1412-60, 00407-1413, 00407-1413-10, 00407-1413-11, 00407-1413-30, 00407-1413-50, 00407-1413-51, 00407-1413-53 and 41 more |
| Lot numbers | 14301544 |
| Expiration dates | 2021-09-21 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0319-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.