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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93391

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 06, 2023
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Bayer Healthcare Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01

D-0145-2024
Recall number
D-0145-2024
Initiated
November 06, 2023
Classification
Class I
Status
Terminated
Quantity
192 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot# 2114228, EXP. 02/29/2024

Distribution pattern

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