Innoveix Pharmaceuticals Inc
FDA Regulatory Profile
Innoveix Pharmaceuticals Inc has 6 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0693-2021 · Class II · Jul 9, 2021
- Latest inspection
- May 27, 2021 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 6 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0693-2021 | Class II | Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only… | Jul 9, 2021 |
| D-0692-2021 | Class II | Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx… | Jul 9, 2021 |
| D-0159-2020 | Class II | Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX… | Oct 10, 2019 |
| D-0157-2020 | Class II | Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix… | Oct 10, 2019 |
| D-0158-2020 | Class II | Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by… | Oct 10, 2019 |
| D-0160-2020 | Class II | Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by… | Oct 10, 2019 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3012907473 | Addison, TX | 2 | May 27, 2021 |