Exact FDA event identifier

Event 78123

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

Open FDA event record

Event summary

Timeline bucket: September 14, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medisca, 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

Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05; jar, 300 ml, white HDPE 38779-0989-07; drum, 15 gallon, Fiber 38779-0989-09; 2.8L, white, HDPE

D-1174-2017

Recall number: D-1174-2017
Initiated: September 14, 2017
Classification: Class II
Status: Terminated
Recalling firm: Medisca, Inc.
Quantity: 34,600 g

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.

Code information

Lots# 143595/A,143595/B,143595/D, Exp 02/28/20

Distribution pattern

Nationwide in the USA