Exact FDA event identifier

Event 78657

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

Open FDA event record

Event summary

Timeline bucket: September 05, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Simple Diagnostics, 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

Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05

D-0134-2018

Recall number: D-0134-2018
Initiated: September 05, 2017
Classification: Class II
Status: Terminated
Recalling firm: Simple Diagnostics, Inc.
Quantity: 150,250 alcohol pads

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility and cGMP Deviations

Code information

Lot # SD2070420925 Exp. Date 09/2019, and Lot # SD2070421201 and Lot # SD2070420601, Exp. Date 12/2019

Distribution pattern

Product was distributed throughout the United States