Class III · Low risk
Fludeoxyglucose F 18 Injection
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Fludeoxyglucose F 18 Injection (Fludeoxyglucose F-18)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
76318-0334-50
Compare with the code on your package — it is the most precise check available.
Drug: Fludeoxyglucose
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Fludeoxyglucose F 18 Fludeoxyglucose F-18 NDC 76318-0334 |
300 mCi/mL | Injection, Solution Intravenous |
Massachusetts General Hospital | Rx |
- Recalling firm
- The General Hospital Corporation
- NDC code
- 76318-334-50
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0288-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fludeoxyglucose recalls
See all
Class II · Moderate risk
Fludeoxyglucose F 18 Injection USP
cGMP Deviation
Other sterility / contamination recalls from 2021
All sterility / contamination recalls
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