CLASS II Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
Fludeoxyglucose F 18 Injection recalled by The General Hospital
The General Hospital is recalling Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution glass. The recall was initiated on 17 Feb 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0288-2021
- FDA event ID
- 87384
- Recalling firm
- The General Hospital, Boston, MA
- Brand
- Fludeoxyglucose F 18
- Manufacturer
- Massachusetts General Hospital
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2021
- FDA classified
- 24 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Feb 2021 | Recall initiated by company | |
| 24 Feb 2021 | Classified by FDA | +7 days |
| 3 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to one direct account.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot # P01-021721, exp 02/17/2021
Where was it sold?
Product was distributed to one direct account.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Fludeoxyglucose F-18 recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fludeoxyglucose F 18 Injection recalled | Lantheus MI Radipharmaceuticals | Potency & Assay | PR |
| Drug | CLASS II | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL recalled | Petnet Solution | Manufacturing (CGMP) Deviations | CA |