FDA recall D-1665-2019

RXQ Compounding LLC · Class II · drug

Product

HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89; b) 55 ML NDC 70731-0114-95] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.

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-1665-2019