The General Hospital Corporation: Drug Recall

Recall #D-0288-2021 · 02/17/2021

Class II: Risk

Recall Details

Recall Number
D-0288-2021
Classification
Class II
Product Type
Drug
Recalling Firm
The General Hospital Corporation
Status
Terminated
Date Initiated
02/17/2021
Location
Boston, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 mL vial

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

Product was distributed to one direct account.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.