Recall events
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Event 93391
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
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
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.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[99]
FDA event record
· Exact recall-number query on openFDA
