VITRAKVI oral solution recalled over sterility concerns

Recall date

November 6, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bayer Healthcare Pharmaceuticals Inc. recalls VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceutic…

Recall number

D-0145-2024

FDA classification

Class I

Brand / firm

Bayer Healthcare Pharmaceuticals Inc.

Sold / distributed

Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.

Why it was recalled

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01