Recalls / Class I
Class ID-0145-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot# 2114228, EXP. 02/29/2024
Why it was recalled
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Recalling firm
- Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Bayer Blvd, Whippany, New Jersey 07981-1544
Distribution
- Quantity
- 192 bottles
- Distribution pattern
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
Timeline
- Recall initiated
- 2023-11-06
- FDA classified
- 2023-12-07
- Posted by FDA
- 2023-12-06
- Terminated
- 2024-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0145-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.