VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer H...
FDA Recall #D-0145-2024 — Class I — November 6, 2023
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
Reason for Recall
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Recalling Firm
Bayer Healthcare Pharmaceuticals Inc. — Whippany, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
192 bottles
Distribution
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Code Information
Lot# 2114228, EXP. 02/29/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated