Bayer Healthcare Pharmaceuticals Inc. recalls VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceutica
Recalled December 6, 2023 · FDA recall D-0145-2024 · Bayer Healthcare Pharmaceuticals
Hazard
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing · FDA Class I
Units
192 bottles
Sold at
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Description
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
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
Manufacturer(s)
Bayer Healthcare Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →