Asclemed USA Inc.
Asclemed USA Inc. appears in FDA public data with 4 recalls, 0 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0713-2026, Class III) was initiated on July 15, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0713-2026 | Class III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx | July 15, 2026 |
| D-0658-2026 | Class II | Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Onl | June 8, 2026 |
| D-0659-2026 | Class II | Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovach | June 8, 2026 |
| D-0555-2026 | Class II | Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torran | May 14, 2026 |