D-0145-2024 Class I Terminated
FDA drug recall D-0145-2024 was initiated by Bayer Healthcare Pharmaceuticals Inc. on November 6, 2023 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing The recall status is terminated (terminated May 29, 2024). Affected quantity: 192 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 6, 2023
- Initiation Date
- November 6, 2023
- Termination Date
- May 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 bottles
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
Distribution Pattern
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Code Information
Lot# 2114228, EXP. 02/29/2024