FDA recall D-1676-2019

RXQ Compounding LLC · Class II · drug

Product

MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0952-10

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-1676-2019