FDA DrugsClass II
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single...
Published: July 8, 2026Recall ID: D-0658-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Torrance |
| State | CA |
| Openfda › Unii | V13007Z41A |
| Openfda › Route | INFILTRATION |
| Openfda › Spl id | 02db6c14-f841-85bd-e063-6294a90a3bf9 |
| Openfda › Brand name | ACCUCAINE |
| Openfda › Spl set id | 584642a8-9bed-4d86-bfaf-99018c180e34 |
| Openfda › Package ndc | 76420-715-01 |
| Openfda › Product ndc | 76420-715 |
| Openfda › Generic name | LIDOCAINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | LIDOCAINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Asclemed USA, Inc. |
| Openfda › Is original packager | true |
| Event id | 99204 |
| Address 1 | 379 Van Ness Ave Ste 1403 |
| Address 2 | N/A |
| Code info | Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028. |
| Postal code | 90501-7211 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260608 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260702 |
Overview
- Recalling FirmAsclemed USA Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUSA Nationwide