Fluorouracil Injection, Solution
FDA Recall NDC 63323-117
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 Fluorouracil (NDC 63323-117). A significant event, classified as Class I, was initiated on Jun 28, 2019 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Presence of Particulate Matter; glass particulates"
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
June 2019 Class I Recall: Presence of Particulate Matter; glass particulates
Recall Number
Class I Terminated
Presence of Particulate Matter; glass particulates
Jun 28, 2019
Jul 24, 2019
14,016 vials
Recall Profile & Regulatory Data
Event ID
83234
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Sep 20, 2022
Product Description
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Batch or Lot Expiration Information
Lot# Lot 6120420 NDC 63323-117-61, Product Code 101761 and Lot 6120341 NDC 63323-117-69, Product Code NP101761
Affected Packages Involved in this Recall
63323-117-51Product
63323-117-61Product
63323-117-59Product
63323-117-69Product
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.
