VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
Reported: December 6, 2023 Initiated: November 6, 2023 #D-0145-2024
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
Reason for Recall
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Details
- Recalling Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Units Affected
- 192 bottles
- Distribution
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Location
- Whippany, NJ
Frequently Asked Questions
What product was recalled? ▼
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 192 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 6, 2023. Severity: Critical. Recall number: D-0145-2024.
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