FDA Drug recall D-0145-2024
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany,…
- FDA Drug
- Class I
- terminated
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class I recall of VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany,… by Bayer Healthcare Pharmaceuticals, citing microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0145-2024 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-11-06 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bayer Healthcare Pharmaceuticals |
| Distribution | US |
Product
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Reason
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Identifiers
| ndc | 50419-390-01 |
|---|---|
| ndc | 50419-391-01 |
| ndc | 50419-392-01 |
| ndc | 50419-393-02 |
| ndc | 50419-393-03 |
| code_info | Lot# 2114228, EXP. 02/29/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0145-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.