D-0288-2021 Class II Terminated
FDA drug recall D-0288-2021 was initiated by The General Hospital Corporation on February 17, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated March 26, 2021). Affected quantity: 50 mL vial.
Recall Details
- Product Type
- Drugs
- Report Date
- March 3, 2021
- Initiation Date
- February 17, 2021
- Termination Date
- March 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 mL vial
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed to one direct account.
Code Information
Lot # P01-021721, exp 02/17/2021