FDA recall D-1638-2019

RXQ Compounding LLC · Class II · drug

Product

BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30ML NDC: 70731-0137-30] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0137-03

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2019-06-19
Report date: 2019-08-14
Termination date: 2022-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Athens, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1638-2019