Fludeoxyglucose F 18 Injection recalled over sterility concerns

Recall date

February 17, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The General Hospital Corporation recalls Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactur…

Recall number

D-0288-2021

FDA classification

Class II

Brand / firm

The General Hospital Corporation

Sold / distributed

Product was distributed to one direct account.

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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