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FDARecalled Dec 6, 2023 · #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

Hazard

Class I — serious health risk

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Description

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing Classification: Class I Distribution: Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.

Product details

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
Type
Drugs
Manufacturer
Bayer Healthcare Pharmaceuticals Inc.
Model numbers
2114228
UPCs