Fludeoxyglucose F 18 Injection — Class II drug recall D-0288-2021
Terminated recall by The General Hospital Corporation, reported 2021-03-03. Lack of Assurance of Sterility
| Recall number | D-0288-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The General Hospital Corporation, Boston, MA, United States |
| Recall initiated | 2021-02-17 |
| Classified | 2021-02-24 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2021-03-26 |
| Quantity | 50 ml |
| Reason classes | sterility |
| NDC | 76318-0334, 76318-0334-50 |
| Lot numbers | P01-021721 |
| Expiration dates | 2021-02-17 |
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 for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0288-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.