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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93261

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

Open FDA event record

Event summary

Timeline bucket
October 17, 2023
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
VistaPharm 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

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08

D-0126-2024
Recall number
D-0126-2024
Initiated
October 17, 2023
Classification
Class III
Status
Terminated
Recalling firm
VistaPharm LLC
Quantity
Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
ethylene glycol

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Excipient Specifications: high content of ethylene glycol (EG)

Code information

Lot #: 22ZKY1, Exp. 11/27/23; 22ZMC1, Exp. 12/21/23; 22ZTP1, Exp. 03/29/24; 23ZAD1, Exp. 07/07/24.

Distribution pattern

Nationwide USA