Class I
Terminated
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
- Recall Initiated
- November 6, 2023
- Posted
- December 6, 2023
- Recall Number
- D-0145-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 192 bottles
- Firm Location
- Whippany, NJ, United States
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.
Lot / Code Info
Lot# 2114228, EXP. 02/29/2024
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