Vitrakvi Solution, Concentrate
FDA Recall NDC 50419-393
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 Vitrakvi (NDC 50419-393). A significant event, classified as Class I, was initiated on Nov 06, 2023 by Bayer Healthcare Pharmaceuticals Inc.. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing"
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
November 2023 Class I Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class I Terminated
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Nov 06, 2023
Dec 06, 2023
192 bottles
Recall Profile & Regulatory Data
Event ID
93391
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Bayer Healthcare Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Termination Date
May 29, 2024
Product Description
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Batch or Lot Expiration Information
Lot# 2114228, EXP. 02/29/2024
Affected Packages Involved in this Recall
50419-390-01Product
50419-391-01Product
50419-392-01Product
50419-393-02Product
50419-393-03Product
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.
