Fludeoxyglucose F 18 Injection Recall: Lack of Sterility Assurance
The General Hospital Corporation recalls Fludeoxyglucose F 18 Injection (50mL glass vial) due to lack of sterility assurance. This radioactive tracer for PET scans poses risks if not properly sterilized.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
The General Hospital Corporation is recalling Fludeoxyglucose F 18 Injection (50mL glass vial) because it may not be sterile. This radioactive tracer for PET scans could cause infections if used improperly. Read more at govinfonow.com/recall/36510-fludeoxyglucose-f-18-injection-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/36510-fludeoxyglucose-f-18-injection-recall-lack-of-sterility-assurance · Updated October 4, 2026 · FDA enforcement record: FDA #D-0288-2021
Cite this page
“Fludeoxyglucose F 18 Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36510-fludeoxyglucose-f-18-injection-recall-lack-of-sterility-assurance. Based on FDA recall #D-0288-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0288-2021%22&limit=1).
Why it’s dangerous
The product may not be sterile, which could lead to infections if injected. This is a serious risk for patients undergoing PET scans that require radioactive tracers.
Who’s affected
Prescription patients receiving this radioactive tracer for PET scans. Healthcare providers using the product for medical imaging are most at risk.
How to tell if you have this one
Look for the 50mL glass vial labeled Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution. The product was manufactured by Massachusetts General Hospital PET Center in Boston, MA with NDC 76318-334-50 and Lot # P01-021721.
- Brand
The General Hospital Corporation- Category
Drug
What to do — step by step
Check Product Details
Identify the 50mL glass vial labeled Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution.
How this recall unfolded
Recall timeline
FDA terminated this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states there is a lack of assurance of sterility, which could lead to infections. The product is not safe for use without proper sterilization.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0288-2021 (February 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0288-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.