Meitheal Pharmaceuticals, Inc
FDA Regulatory Profile
Meitheal Pharmaceuticals, Inc has 5 FDA recalls (1 Class I), 1 inspection, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0108-2027 · Class III · Oct 8, 2026
- Latest inspection
- May 21, 2025 · NAI
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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 (1 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0108-2027 | Class III | Vecuronium Bromide for Injection, 10mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for… | Oct 8, 2026 |
| D-0109-2027 | Class III | Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for… | Oct 8, 2026 |
| D-0340-2026 | Class II | Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for… | Feb 9, 2026 |
| D-0801-2021 | Class III | Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal… | Sep 3, 2021 |
| D-0286-2021 | Class I | Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC… | Jan 27, 2021 |
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 3013610124 | Chicago, IL | 1 | May 21, 2025 |