Drug product
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50
D-0288-2021
Product summary
- Event
- Event 87384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 mL vial
- Official record key
drug-enforcement:D-0288-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # P01-021721, exp 02/17/2021
Distribution pattern: Product was distributed to one direct account.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility