FDA recall D-0573-2020

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-11-11

Report date

2019-12-04

Termination date

2020-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0573-2020