RecallRadar

FDA Drug recall D-0573-2020

Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Di…

On 2019-12-04 the FDA classified a Class II recall of Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Di… by Auromedics Pharma, citing presence of Foreign Substance: Foreign material found inside the vial.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0573-2020
ClassificationClass II
Statusterminated
Initiated2019-11-11
Published2019-12-04
Last updated2026-09-13 11:52 UTC
CompanyAuromedics Pharma
DistributionUS

Product

Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-165-05.

Reason

Presence of Foreign Substance: Foreign material found inside the vial.

Identifiers

ndc80425-0573-1
ndc0409-1162-18
ndc55150-165-05
ndc67777-419-02
code_infoBatch #: CLC190049, Exp 02/2022

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0573-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.