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Bayer
Issues Voluntary Recall Nationwide of
VITRAKVI
® (
larotrectinib
) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination
2023-11-17
·
BioSpace
WHIPPANY, N.J.--(BUSINESS WIRE)--
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. 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. 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. Product bottle and carton label images and information on the lot number that falls under this recall is available at: Vitrakvi Recall Lot # Photos 11.17.23.pdf (bayer.com)
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 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. 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. 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. 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. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the
U.S. Food and Drug Administration
. © 2023
Bayer
BAYER
, the
Bayer
Cross and
Vitrakvi
are registered trademarks of
Bayer
. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by
Bayer Group
or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in
Bayer
's public reports which are available on the
Bayer
website at . The company assumes no liability whatsoever to update these forward- looking statements or to conform them to future events or developments. PP-VIT-US-1391 11/23 View source version on businesswire.com: Contacts Company Contact: Name: Carolyn Nagle Email: carolyn.nagle@bayer.com Mobile: (201) 419-0337 Source:
Bayer
View this news release online at:
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机构
Bayer AG
US Food & Drug Administration
Bayer SAS
适应症
实体瘤
侵袭性真菌感染
肺炎
[+1]
靶点
NTRK
药物
硫酸拉罗替尼
标准版
¥
16800
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