Recalls / Class II
Class IID-0288-2021
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
- Brand name
- Fludeoxyglucose F 18
- Generic name
- Fludeoxyglucose F-18
- Active ingredient
- Fludeoxyglucose F-18
- Route
- Intravenous
- NDC
- 76318-334
- FDA application
- ANDA204333
- Affected lot / code info
- Lot # P01-021721, exp 02/17/2021
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- The General Hospital Corporation
- Manufacturer
- Massachusetts General Hospital
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 55 Fruit St, N/A, Boston, Massachusetts 02114-2621
Distribution
- Quantity
- 50 mL vial
- Distribution pattern
- Product was distributed to one direct account.
Timeline
- Recall initiated
- 2021-02-17
- FDA classified
- 2021-02-24
- Posted by FDA
- 2021-03-03
- Terminated
- 2021-03-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0288-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.