Fludeoxyglucose F 18 Injection, Solution
FDA Recall NDC 76318-334
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fludeoxyglucose F 18 (NDC 76318-334). A significant event, classified as Class II, was initiated on Feb 17, 2021 by Massachusetts General Hospital. The reported reason for this action was: "Lack of Assurance of Sterility"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility
Feb 17, 2021
Mar 03, 2021
50 mL vial
Recall Profile & Regulatory Data
Event ID
87384
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
The General Hospital Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to one direct account.
Termination Date
Mar 26, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# P01-021721, exp 02/17/2021
Affected Packages Involved in this Recall
76318-334-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
