Bayer Healthcare Pharmaceuticals Inc.: Drug Recall
Recall #D-0145-2024 · 11/06/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0145-2024
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Status
- Terminated
- Date Initiated
- 11/06/2023
- Location
- Whippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 bottles
Reason for Recall
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
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
Distribution Pattern
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Other Recalls by Bayer Healthcare Pharmaceuticals Inc.
- Class I: Dangerous 10/01/2021
- Class I: Dangerous 10/01/2021
- Class II: Risk 10/01/2021
- Class I: Dangerous 10/01/2021
- Class II: Risk 10/01/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.