Petnet Solution Recalls Fludeoxyglucose F 18 Injection Due to cGMP Deviation
Petnet Solution Inc. voluntarily recalled 28 doses of Fludeoxyglucose F 18 Injection in California due to a cGMP deviation.
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 and is voluntary, initiated due to a cGMP deviation without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Petnet Solution Inc. has voluntarily recalled 28 doses of Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only. The product was manufactured by PETNET Solutions, Inc., in Knoxville, TN, and distributed within the state of California.
The recall was initiated due to a Current Good Manufacturing Practice (cGMP) deviation. The affected product is identified by Batch # BN-3350 and specific prescription numbers listed in the recall documentation. The recall was classified as Class II by the FDA.
Consumers and healthcare providers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall status is listed as Terminated.
The recalled product
- Product
- Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intravenous Use Only, Manufactured by PETNET Solutions, Inc., Knoxville, TN
- Manufacturer
- Petnet Solution Inc
- Category
- Drug — Radiopharmaceutical
- Hazard
- Affected units
- 28
Distribution
Distributed in 1 state:
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