Draximage MAA — Class II drug recall D-1189-2022
Terminated recall by Jubilant Draximage Inc, reported 2022-07-20, distributed nationwide. Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
| Recall number | D-1189-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Draximage Inc, Kirkland, Canada |
| Recall initiated | 2022-06-16 |
| Classified | 2022-07-08 |
| Reported by FDA | 2022-07-20 |
| Terminated | 2023-07-25 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 65174-0270, 65174-0270-30 |
| Lot numbers | 1H005 |
| Expiration dates | 2023-11-30 |
Product
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.
Reason for recall
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
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-1189-2022. 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.