Class II · Moderate risk
Fludeoxyglucose F 18 Injection
Lack of Assurance of Sterility
Fludeoxyglucose F 18 Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
Affected NDC
11994-0015-01
Compare with the code on your package — it is the most precise check available.
Drug: Fludeoxyglucose
- Recalling firm
- Lantheus MI Radipharmaceuticals Inc.
- NDC code
- 11994-015-01
- Origin
- PR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0942-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 II · Moderate risk
Fludeoxyglucose F 18 Injection USP
cGMP Deviation
Other impurity / degradation recalls from 2017
All impurity / degradation recalls
Class II · Moderate risk
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class III · Low risk
Penicillin V Potassium for Oral Solution
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class III · Low risk
Isradapine Capsules USP 2.5 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
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