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

FDA recall notice · announced March 3, 2021 · The General Hospital

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

Lack of Assurance of Sterility

Notes

Distribution: Product was distributed to one direct account.
Lot/code information: Lot # P01-021721, exp 02/17/2021
Quantity: 50 mL vial
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.