Innovative Intrathecal Solutions, Inc.
FDA Regulatory Profile
Innovative Intrathecal Solutions, Inc. has 5 FDA recalls, 4 inspections, 0 510(k) clearances and 2 compliance actions on record.
- Latest recall
- D-1098-2020 · Class II · Mar 26, 2020
- Latest inspection
- Oct 26, 2021 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | 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 | 4 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1098-2020 | Class II | Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING… | Mar 26, 2020 |
| D-1099-2020 | Class II | Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only… | Mar 26, 2020 |
| D-1097-2020 | Class II | Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING… | Mar 26, 2020 |
| D-1096-2020 | Class II | MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, Injectable, Rx only… | Mar 26, 2020 |
| D-1095-2020 | Class II | Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY… | Mar 26, 2020 |
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.