Compounded Lyophilized AOD-9604 — Class II drug recall D-0693-2021
Completed recall by Innoveix Pharmaceuticals Inc, reported 2021-07-28, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0693-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Innoveix Pharmaceuticals Inc, Addison, TX, United States |
| Recall initiated | 2021-07-09 |
| Classified | 2021-07-20 |
| Reported by FDA | 2021-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,316 vials |
| Reason classes | sterility |
| Lot numbers | AOD205, AOD210, AOD215, AOD220 |
| Expiration dates | 2021-11-09, 2021-11-18, 2021-12-15, 2022-01-20 |
Product
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason for recall
Lack of Assurance of Sterility
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-0693-2021. 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.