Drug product
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
D-0942-2017
Product summary
- Event
- Event 77433
- Status
- Terminated
- Classification
- Class III
- Quantity
- 26 doses
- Official record key
drug-enforcement:D-0942-2017
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Code information: Lot: FDG170518-01, exp 5/18/2017
Distribution pattern: Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification