VITRAKVI — Class I drug recall D-0145-2024
Terminated recall by Bayer Healthcare Pharmaceuticals Inc., reported 2023-12-06, distributed nationwide. Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompac
| Recall number | D-0145-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ, United States |
| Recall initiated | 2023-11-06 |
| Classified | 2023-12-07 |
| Reported by FDA | 2023-12-06 |
| Terminated | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 192 bottles |
| Reason classes | microbial contamination, sterility, specification failure |
| NDC | 50419-0390, 50419-0390-01, 50419-0391, 50419-0391-01, 50419-0392, 50419-0392-01, 50419-0393, 50419-0393-02, 50419-0393-03 |
| Lot numbers | 2114228 |
| Expiration dates | 2024-02-29 |
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 for recall
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0145-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.