Class II · Moderate risk
Fludeoxyglucose F 18 Injection
Lack of Assurance of Sterility
Fludeoxyglucose F 18 Injection USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviation
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
Drug: Fludeoxyglucose
- Recalling firm
- Petnet Solution Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-579-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fludeoxyglucose recalls
See all
Class III · Low risk
Fludeoxyglucose F 18 Injection
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Other cgmp deviation recalls from 2013
All cgmp deviation recalls
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