Assurance Infusion
FDA Regulatory Profile
Assurance Infusion has 118 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0774-2020 · Class II · Dec 20, 2019
- Latest inspection
- Dec 3, 2019 · OAI
Reviewing Assurance Infusion as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check Assurance Infusion yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 118 | 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 | 1 | 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-0774-2020 | Class II | TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0775-2020 | Class II | TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0779-2020 | Class II | TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0686-2020 | Class II | BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0736-2020 | Class II | HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 | Dec 20, 2019 |
| D-0668-2020 | Class II | BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion… | Dec 20, 2019 |
| D-0699-2020 | Class II | BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0759-2020 | Class II | MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0722-2020 | Class II | CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0711-2020 | Class II | BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0691-2020 | Class II | BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0730-2020 | Class II | FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0716-2020 | Class II | BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0778-2020 | Class II | TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0675-2020 | Class II | BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion… | Dec 20, 2019 |
| D-0772-2020 | Class II | TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0676-2020 | Class II | BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0689-2020 | Class II | BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713)… | Dec 20, 2019 |
| D-0696-2020 | Class II | BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 2019 |
| D-0688-2020 | Class II | BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Dec 20, 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 3015617746 | Houston, TX | 1 | Dec 3, 2019 |