FDA recall D-1659-2019

RXQ Compounding LLC · Class II · drug

Product

FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0207-89

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-1659-2019