VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceutica
Summary
The FDA issued a Class I for VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufac by Bayer Healthcare Pharmaceuticals Inc.. Reason: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stab.
Details
Source
Drug Recall
External ID
D-0145-2024
Action Date
2023-12-06
Status
Terminated
Category
drug
Product Description
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Lot/Code Info: Lot# 2114228, EXP. 02/29/2024
Quantity Affected: 192 bottles
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-06
Company
Whippany, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bayer Healthcare Pharmaceuticals Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bayer Healthcare Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bayer Healthcare Pharmaceuticals Inc. have FDA actions?
Bayer Healthcare Pharmaceuticals Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0145-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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