CLASS I Drug recall · Reported 6 Dec 2023 · FDA Enforcement Report
Vitrakvi (larotractenib) oral solution, 20mg/mL recalled
Bayer Healthcare Pharmaceuticals is recalling Vitrakvi (larotractenib) oral solution, 20mg/mL, distributed nationwide in the US. The recall was initiated on 6 Nov 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0145-2024
- FDA event ID
- 93391
- Recalling firm
- Bayer Healthcare Pharmaceuticals, Whippany, NJ
- Brand
- Vitrakvi
- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Nov 2023
- FDA classified
- 7 Dec 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 6 Nov 2023 | Recall initiated by company | |
| 6 Dec 2023 | Published in enforcement report | +30 days |
| 7 Dec 2023 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Where it was distributed
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Which lots are affected?
Lot# 2114228, EXP. 02/29/2024
Where was it sold?
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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