Vitrakvi recall: Sterility Concern
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981.…
Why was Vitrakvi recalled?
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 2114228, EXP. 02/29/2024
- Product
- VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981.…
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Quantity
- 192 bottles
- Distribution
- Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.
- Recall date
- December 6, 2023
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)