FDA recall D-1707-2019

Product

STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 10 ML vial: 70731-0188-10; NDC 30 ML vial: 70731-0188-30; NDC 50 ML vial: 70731-0188-50

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-1707-2019