FDA DrugsClass II
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di...
Published: July 8, 2026Recall ID: D-0659-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Torrance |
| State | CA |
| Openfda › Unii | EC2CNF7XFP |
| Openfda › Route › 1 | EPIDURAL |
| Openfda › Route › 2 | INFILTRATION |
| Openfda › Route › 3 | INTRACAUDAL |
| Openfda › Route › 4 | PERINEURAL |
| Openfda › Rxcui | 1737566 |
| Openfda › Spl id | 4d6e159a-1dbb-c957-e063-6394a90aa5f7 |
| Openfda › Brand name | LIDOCAINE HYDROCHLORIDE |
| Openfda › Spl set id | def640dd-bce2-4c18-9ee1-4a1cd5852e89 |
| Openfda › Package ndc › 1 | 85766-187-01 |
| Openfda › Package ndc › 2 | 85766-187-25 |
| Openfda › Product ndc | 85766-187 |
| Openfda › Generic name | LIDOCAINE HYDROCHLORIDE ANHYDROUS |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | LIDOCAINE HYDROCHLORIDE ANHYDROUS |
| Openfda › Manufacturer name | Sportpharm LLC |
| Openfda › Application number | ANDA208017 |
| Openfda › Original packager product ndc | 65282-1605 |
| Event id | 99204 |
| Address 1 | 379 Van Ness Ave Ste 1403 |
| Address 2 | N/A |
| Code info | Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, 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