Status
Terminated
Drug Enforcement D-0145-2024
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Classification
Class I
Report Date
December 6, 2023
Termination Date
May 29, 2024
Product Information
- 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
- Product quantity
- 192 bottles
- Reason for recall
- Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Location & Firm
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Address
-
100 Bayer Blvd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0145-2024
- Event ID
- 93391
- Recall initiation date
- November 6, 2023
- Center classification date
- December 7, 2023
- Code info
- Lot# 2114228, EXP. 02/29/2024
- More code info
- —