Why it was recalled
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
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
Lot numbers, UPCs & expiration codes
Lot# 2114228, EXP. 02/29/2024
Where it was sold
Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0145-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 6, 2023
- FDA report date
- Dec 6, 2023
- Quantity
- 192 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0145-2024, exactly as published.
Show all FDA fields
- City
- Whippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93391
- Address
- 100 Bayer Blvd
- Code information
- Lot# 2114228, EXP. 02/29/2024
- Postal code
- 07981-1544
- Report date
- Dec 6, 2023
- Product type
- Drugs
- Recall number
- D-0145-2024
- Classification
- Class I
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Product quantity
- 192 bottles
- Termination date
- May 29, 2024
- Reason for recall
- Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Recall initiation date
- Nov 6, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 7, 2023