Drug recall
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only…
FDA recall event 99204 · Class II · Asclemed USA Inc.
Key facts
| Event ID | 99204 |
|---|---|
| Recall numbers | D-0658-2026, D-0659-2026 |
| Recalling firm | Asclemed USA Inc. |
| Product type | Drugs |
| Products | 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., Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility |
| Initiation date | Jun 8, 2026 |
| Report date | Jul 8, 2026 |
| City | Torrance |
| State | CA |
| Country | United States |
| FEI number | 3001452204 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: