Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.

Recall Number: D-0658-2026

Firm: Asclemed USA Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260708

Initiation Date: 20260608

Termination Date:

Lack of Assurance of Sterility

Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.