FDA Recall D-0145-2024
Bayer Healthcare Pharmaceuticals Inc. · Whippany, NJ
Class I — life-threatening Terminated 205 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0145-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Recall initiated
- 2023-11-06
- Classified by FDA Center
- 2023-12-07
- FDA published
- 2023-12-06
- Terminated
- 2024-05-29
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Firm location
- Whippany, NJ
Drug identification
- Brand name(s)
- VITRAKVI
- Generic name(s)
- LAROTRECTINIB
- Manufacturer(s)
- Bayer HealthCare Pharmaceuticals Inc.
- NDC(s)
50419-390, 50419-391, 50419-392, 50419-393- Route(s)
- ORAL