Recall: D-0288-2021
Class II - Potentially Harmful
Class IIClassification
2021-02-17Initiated
TerminatedStatus
The General Hospital CorporatiFirm
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
Reason
Lack of Assurance of Sterility
Distribution
Product was distributed to one direct account.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.