April 2013 FDA Recall Drug by Insight Instruments, Inc.
D-1056-2014 - Marketed without an Approved NDA/ANDA.

This Class II drug recall was voluntarily initiated by Insight Instruments, Inc. on April 24, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1056-2014

Reason for Recall
Marketed without an Approved NDA/ANDA.
Initiated
04-24-2013
Reported
02-12-2014
Quantity
316,464 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65107
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Insight Instruments, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-02-2017
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

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