Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot # P01-021721, exp 02/17/2021
Where it was sold
Product was distributed to one direct account.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0288-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 17, 2021
- FDA report date
- Mar 3, 2021
- Quantity
- 50 mL vial
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The General Hospital Corporation
Original FDA data
Every field from FDA enforcement report D-0288-2021, exactly as published.
Show all FDA fields
- City
- Boston
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 87384
- Address
- 55 Fruit St
- Code information
- Lot # P01-021721, exp 02/17/2021
- Postal code
- 02114-2621
- Report date
- Mar 3, 2021
- Product type
- Drugs
- Recall number
- D-0288-2021
- Classification
- Class II
- Recalling firm
- The General Hospital Corporation
- Product quantity
- 50 mL vial
- Termination date
- Mar 26, 2021
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Feb 17, 2021
- Initial firm notification
- Telephone
- Center classification date
- Feb 24, 2021