Asclemed recalls
FDA enforcement reports naming Asclemed USA Inc. as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Jul 29, 2026
- Jul 29, 2026Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single…Drug · Asclemed USA Inc.Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scanClass III
- Jul 8, 2026Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose a…Drug · Asclemed USA Inc.Lack of Assurance of SterilityClass II
- Jul 8, 2026Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distribut…Drug · Asclemed USA Inc.Lack of Assurance of SterilityClass II
- Jun 10, 2026Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceut…Drug · Asclemed USA Inc.CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.Class II