Class II · Moderate risk
Fludeoxyglucose F 18 Injection
Lack of Assurance of Sterility
Most common reason: cGMP deviation (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fludeoxyglucose. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
cGMP Deviation
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