Lidocaine HCl Injection recalled over foreign material

Recall date

November 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AuroMedics Pharma LLC recalls Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per…

Recall number

D-0573-2020

FDA classification

Class II

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.