# FDA recall D-0145-2024

> **Bayer Healthcare Pharmaceuticals Inc.** · Class I · drug recall initiated 2023-11-06.

## 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

## Distribution

Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.

## Key facts

- **Recall number:** D-0145-2024
- **Recalling firm:** Bayer Healthcare Pharmaceuticals Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-11-06
- **Report date:** 2023-12-06
- **Termination date:** 2024-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Whippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0145-2024

## Citation

> AI Analytics. FDA recall D-0145-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0145-2024. Source: US FDA. Licensed CC0.

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