Class II · Moderate risk Terminated
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by…
Reason Lack of Assurance of Sterility
Is Fludeoxyglucose recalled?
3 FDA recalls mention Fludeoxyglucose. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fludeoxyglucose.
Class III · Low risk Terminated
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI…
Reason Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Class II · Moderate risk Terminated
Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc…
Reason cGMP Deviation
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