FDA-Drug2023-12-06Class I
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Bayer Healthcare Pharmaceuticals Inc.
Hazard
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Sold states
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Affected count
192 bottles
Manufactured in
100 Bayer Blvd, Whippany, NJ, United States
Products
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0145-2024Don't want to check this manually?
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