November 2023 FDA Recall Vitrakvi by Bayer Healthcare Pharmaceuticals Inc.
D-0145-2024 - Microbial Contamination of Non-Sterile Products

This Class I drug recall was voluntarily initiated by Bayer Healthcare Pharmaceuticals Inc. on November 6, 2023 for the product Vitrakvi. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0145-2024

Reason for Recall
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Initiated
11-06-2023
Reported
12-06-2023
Quantity
192 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93391
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bayer Healthcare Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-29-2024
Product Description About Product Description
Full technical description of the product.
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

50419-390-01 Vitrakvi
50419-391-01 Vitrakvi
50419-392-01 Vitrakvi
50419-393-02 Vitrakvi
50419-393-03 Vitrakvi