PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: December 4, 2019 Initiated: November 11, 2019 #D-0573-2020

Product Description

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.

Details

Recalling Firm
AuroMedics Pharma LLC
Units Affected
111,850 vials
Distribution
Nationwide in the USA
Location
East Windsor, NJ

Frequently Asked Questions

What product 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.. Recalled by AuroMedics Pharma LLC. Units affected: 111,850 vials.
Why was this product recalled?
Presence of Foreign Substance: Foreign material found inside the vial.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 4, 2019. Severity: Moderate. Recall number: D-0573-2020.