Fludeoxyglucose F 18 Injection Recalled for Lack of Sterility Assurance
The General Hospital Corporation is recalling Fludeoxyglucose F 18 Injection due to a lack of assurance of sterility. The product was distributed to one direct account.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is a lack of assurance of sterility rather than a confirmed contamination event, fitting the criteria for a moderate severity score.
Plain-English summary
The General Hospital Corporation is recalling Fludeoxyglucose F 18 Injection, a prescription radiopharmaceutical used for diagnostic imaging. The recall was initiated because of a lack of assurance of sterility for the product.
The affected product is identified as Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, packaged in 50 mL glass vials. The specific lot number is P01-021721, with an expiration date of 02/17/2021. The product was manufactured by Massachusetts General Hospital PET Center in Boston, MA.
The recall is limited to one direct account. No specific instructions for consumers are provided in the source text, as the product is a prescription drug distributed to a medical facility.
The recalled product
- Product
- FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18)
- Brand
- FLUDEOXYGLUCOSE F 18
- Manufacturer
- The General Hospital Corporation
- Category
- Drug — Radiopharmaceutical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # P01-021721
- exp 02/17/2021
Distribution
Distribution scope not specified by the agency.
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