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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64018

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

Open FDA event record

Event summary

Timeline bucket
January 03, 2013
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Mobius Therapeutics LLC

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

Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA.

D-809-2013
Recall number
D-809-2013
Initiated
January 03, 2013
Classification
Class I
Status
Terminated
Recalling firm
Mobius Therapeutics LLC
Quantity
83 boxes

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
found to be contaminated with yeast

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.

Code information

Lot #: M086920 and M098260, Exp. 08/2013

Distribution pattern

Nationwide and Military and Government Consignees