Home / Recalls / Bayer Healthcare Pharmaceuticals Inc. / D-0145-2024

D-0145-2024 Class I Terminated

Recalled by Bayer Healthcare Pharmaceuticals Inc. — Whippany, NJ

Recall Details

Product Type
Drugs
Report Date
December 6, 2023
Initiation Date
November 6, 2023
Termination Date
May 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
192 bottles

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

Reason for Recall

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

Distribution Pattern

Product was distributed to specialty pharmacies and distributors nationwide who may have further distributed the product.

Code Information

Lot# 2114228, EXP. 02/29/2024

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