Exact FDA event identifier

Event 65107

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

Event summary

Timeline bucket: April 24, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Insight Instruments, 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

Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.

D-1056-2014

Recall number: D-1056-2014
Initiated: April 24, 2013
Classification: Class II
Status: Terminated
Recalling firm: Insight Instruments, Inc.
Quantity: 316,464 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed without an Approved NDA/ANDA.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA.

Code information

Product Number (s): 60010, 40201, 40202, 40203, 40204, 40205, 40206.

Distribution pattern

Nationwide and Puerto Rico