FDA DrugsClass II
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed ...
Published: June 10, 2026Recall ID: D-0554-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Additional Source Details
| Field | Value |
|---|---|
| City | Wilmington |
| State | MA |
| Openfda › Upc | 0365282160515 |
| 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 | 447bfde4-fff3-32a6-e063-6394a90a667e |
| Openfda › Brand name | LIDOCAINE HYDROCHLORIDE |
| Openfda › Spl set id | e8ba012a-08a9-4f67-9f88-3284377e80be |
| Openfda › Package ndc | 65282-1605-1 |
| Openfda › Product ndc | 65282-1605 |
| Openfda › Generic name | LIDOCAINE HYDROCHLORIDE ANHYDROUS |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | LIDOCAINE HYDROCHLORIDE ANHYDROUS |
| Openfda › Manufacturer name | Spectra Medical Devices, LLC |
| Openfda › Application number | ANDA208017 |
| Openfda › Is original packager | true |
| Event id | 98976 |
| Address 1 | 299 Ballardvale St |
| Address 2 | Ste 1 |
| Code info | Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028. |
| Postal code | 01887-1066 |
| Report date | 20260610 |
| Product type | Drugs |
| Product quantity | 210625 ampules |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260512 |
| Initial firm notification | Letter |
| Center classification date | 20260602 |
Overview
- Recalling FirmSpectra Medical Devices, Llc
- StatusOngoing
- Risk LevelClass II
- DistributionUSA Nationwide