FDA-Drug2021-03-03Class II

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

The General Hospital Corporation
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed to one direct account.
Affected count
50 mL vial
Manufactured in
55 Fruit St, N/A, Boston, MA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2021

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