Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cornea Coat Recalled by Insight Instruments, Inc. Due to Marketed without an Approved NDA/ANDA.

Date: April 24, 2013
Company: Insight Instruments, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Insight Instruments, Inc. directly.

Affected Products

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.

Quantity: 316,464 kits

Why Was This Recalled?

Marketed without an Approved NDA/ANDA.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Insight Instruments, Inc.

Insight Instruments, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report