FDA Drug Class I — Most Serious

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

Hazard

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

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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
Brand
Bayer Healthcare Pharmaceuticals Inc.
UPC
Lot# 2114228, EXP. 02/29/2024

Units Affected

192 bottles

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