FDA recall D-0288-2021

The General Hospital Corporation · Class II · drug

Product

Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50

Reason for recall

Lack of Assurance of Sterility

Distribution

Product was distributed to one direct account.

Key facts

Status: Terminated
Initiation date: 2021-02-17
Report date: 2021-03-03
Termination date: 2021-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Boston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2021