FDA Drug recall D-0979-2020
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990…
- FDA Drug
- Class II
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990… by Fusion Iv Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0979-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-15 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fusion Iv Pharmaceuticals |
| Distribution | US |
Product
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 10012019+52984, Exp 1/19/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0979-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.