Drug product
Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
D-579-2013
Product summary
- Event
- Event 64635
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 doses
- Official record key
drug-enforcement:D-579-2013
Official wording
Reason: cGMP Deviation
Code information: Batch # BN-3350 Rx #s: [38126044] [38126058] [38126059] [38126021] [38126022] [38126023] [38125981] [38125991] [38125992] [38126016] [38126017] [38126004] [38126005] [38126006] [38126007] [38126057] [38125999] [38126036] [38126037] [38126038] [38125998] [38126033]
Distribution pattern: Within the state of CA.
Derived failure modes
-
Manufacturing or process control
cGMP Deviation