FDA recall D-579-2013

Product

Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN

Reason for recall

cGMP Deviation

Distribution

Within the state of CA.

Key facts

Status

Terminated

Initiation date

2013-02-22

Report date

2013-06-12

Termination date

2013-06-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-579-2013