Bayer Recalls VITRAKVI® (Larotrectinib) Oral Solution 20 mg/mL Due to Microbial Contamination


Medical Recalls

Taro Pharmaceuticals U.S.A. Clobetasol Propionate Ointment
mylan pharmaceuticals insulin glargine
medical recall

Vitrakvi Bottle and Box at Different Angles.


Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.

To date, Bayer has not received any adverse events related to this recall.

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

Bayer notified all distributors and pharmacies of this recall on November 8, 2023. Bayer has engaged Qualanex to manage the recall of the product down to the consumer level. Qualanex has notified Vitrakvi® distributors via a recall notification letter and will arrange for the return of the recalled lot from distributors, specialty pharmacies, and consumers.

Consumers who have the recalled Vitrakvi® product should immediately stop use of this particular lot of product and contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to Vitrakvi® Oral Solution 20 mg/mL.

Source: FDA

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

Consumer Contact: -

Consumers with general questions regarding this recall can contact Qualanex via e-mail at Recall@qualanex.com or toll free at 888-280-2043, Monday-Friday between the hours of 7 a.m. and 4 p.m. Central Standard Time.

Patients or prescribers who have questions regarding the recall can contact Bayer Medical Information Call Center at 888-842-2937, Monday-Friday between the hours of 8:30 a.m. and 8:00 p.m. Eastern Standard Time.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

Risk Statement: Given that Vitrakvi® is indicated for the treatment of solid tumors that are NTRK gene fusion positive, it is expected that patients on Vitrakvi® may be immunocompromised. Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression. Therefore, there is a reasonable probability that ingestion of Penicillium brevicompactum in patients on Vitrakvi® with underlying immunosuppression may result in invasive fungal infections of the blood or pneumonia that can be life-threatening. 


Report a Problem With This Product

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

Related Posts

recalled h&natural products
G.A. Mart Recalls H&NATURAL TejoRoot and H&NATURAL Brazil Seed Dietary Supplements
G.A. Mart Recalls H&NATURAL TejoRoot and H&NATURAL Brazil Seed Dietary Supplements
medical recall
Backstage Center Recalls Approximately 280 Bottles of Mislabeled Alipotec Raiz de Tejocote
Backstage Center Recalls Approximately 280 Bottles of Mislabeled Alipotec Raiz de Tejocote
nordic naturals baby’s vitamin d3 liquid
Nordic Naturals Recalls Baby’s Vitamin D3 Liquid
Nordic Naturals Recalls Baby's Vitamin D3 Liquid
arize herbal dietary supplement empty box
Today The World Recalls All Lots of Arize Herbal Dietary Supplement Capsules
Today The World Recalls All Lots of Arize Herbal Dietary Supplement Capsules

Latest Posts

recalled eye ointment
Brassica Pharma Pvt. Ltd. Recalls Eye Ointment products
lqnn inc banh ba xa and varieties of banh pia
LQNN Inc. Recalls Banh Ba Xa and Varieties of Banh Pia
recalled h&natural products
G.A. Mart Recalls H&NATURAL TejoRoot and H&NATURAL Brazil Seed Dietary Supplements
medical recall
Backstage Center Recalls Approximately 280 Bottles of Mislabeled Alipotec Raiz de Tejocote
polaris model year 2023 650 matryx sks 146 snowmobile
Polaris Recalls MATRYX Snowmobiles Equipped with PATRIOT 650 and 850 Engines

Leave a Reply

Your email address will not be published. Required fields are marked *

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.