Drug recall D-0145-2024
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
Reason for recall
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Lots and codes
Lot# 2114228, EXP. 02/29/2024
Recall details
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ
- Quantity
- 192 bottles
- Distribution
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 6, 2023
- Terminated
- May 29, 2024
Related products
- Vitrakvi – drug information
- NDC 50419-392 Vitrakvi · Larotrectinib 20 mg/mL · Bayer HealthCare Pharmaceuticals Inc.
- NDC 50419-393 Vitrakvi · Larotrectinib 20 mg/mL · Bayer HealthCare Pharmaceuticals Inc.
- NDC 50419-391 Vitrakvi · Larotrectinib 100 mg/1 · Bayer HealthCare Pharmaceuticals Inc.
- NDC 50419-390 Vitrakvi · Larotrectinib 25 mg/1 · Bayer HealthCare Pharmaceuticals Inc.