Drug 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
D-0145-2024
Product summary
- Event
- Event 93391
- Status
- Terminated
- Classification
- Class I
- Quantity
- 192 bottles
- Official record key
drug-enforcement:D-0145-2024
Official wording
Reason: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Code information: Lot# 2114228, EXP. 02/29/2024
Distribution pattern: Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Derived failure modes
-
Microbial contamination
Microbial Contamination