FDA Drug recall D-0693-2021
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-3…
- FDA Drug
- Class II
- completed
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-3… by Innoveix Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0693-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2021-07-09 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Innoveix Pharmaceuticals |
| Distribution | US |
Product
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0693-2021%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.