FDAClass IIFebruary 12, 2014

Cornea Coat recall

Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL…

Why was Cornea Coat recalled?

Marketed without an Approved NDA/ANDA.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL…
Recalling firm
Insight Instruments, Inc.
Quantity
316,464 kits
Distribution
Nationwide and Puerto Rico
Recall date
February 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls