Bayer Recalls Vitrakvi Oral Solution 20 Mg/mL Due To Microbial Contamination

(RTTNews) - Bayer (BAYZF.PK, BAYRY.PK, BYR.L) is voluntarily recalling one lot of its cancer drug Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles in the U.S. due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.

However, the company has not received any adverse event reports related to the lot to date.

The recall involves a lot of Vitrakvi® is packaged in a 100mL glass bottle with NDC# 50419-392-01 and is identified with Lot# 2114228 and an expiration date of February 29, 2024.

The Lot# 2114228 was distributed to wholesale distributors and specialty pharmacies nationwide between January 3, 2023, and February 13, 2023.

Customers who have the recalled lot should immediately stop use of the drug and contact their physician or healthcare provider, the company said.

The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.