FDA recall D-1248-2019

Aurobindo Pharma USA Inc. · Class I · drug

Product

Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05

Reason for recall

Presence of Particulate Matter: One vial was found to contain a hair.

Distribution

Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.

Key facts

Status: Terminated
Initiation date: 2019-03-28
Report date: 2019-04-17
Termination date: 2024-04-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1248-2019