FDA Drug recall D-0288-2021
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts…
- FDA Drug
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts… by The General Hospital, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0288-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-17 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The General Hospital |
| Distribution | n/a |
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
Lack of Assurance of Sterility
Identifiers
| ndc | 76318-334-50 |
|---|---|
| code_info | Lot # P01-021721, exp 02/17/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0288-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.