FDA recall D-0145-2024

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2023-11-06

Report date

2023-12-06

Termination date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Whippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0145-2024