FDA recall D-1668-2019

RXQ Compounding LLC · Class II · drug

Product

Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0999-30

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-1668-2019