FDAFDA · Food and drugs·Recall number D-0145-2024
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Published December 6, 2023 · Recall initiated: November 6, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VITRAKVI
- Manufacturer
- Bayer Healthcare Pharmaceuticals Inc.
- Distributor
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Lot
- Lot# 2114228, EXP. 02/29/2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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