Drugplain

Eye Itch Relief .25 mg/mL

ketotifen fumarate · SOLUTION/ DROPS · TOPCO ASSOCIATES LLC

2 Recalls on Record
Plain English

Eye Itch Relief is a solution/ drops containing ketotifen fumarate at .25 mg/mL, taken ophthalmic. Manufactured by TOPCO ASSOCIATES LLC.

Key Facts

Brand Name
Eye Itch Relief
Generic Name
ketotifen fumarate
NDC Code (Product)
36800-097
Manufacturer
TOPCO ASSOCIATES LLC
Strength
.25 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
NDA021996
Marketing Start
03/15/2022

Recall History

2 Recalls on Record
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II09/03/2020

Akorn, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Eye Itch Relief used for?

Eye Itch Relief contains ketotifen fumarate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Eye Itch Relief a controlled substance?

Eye Itch Relief is not classified as a controlled substance by the DEA.

What is the generic name for Eye Itch Relief?

The generic name for Eye Itch Relief is ketotifen fumarate. There are 5 other brand versions of ketotifen fumarate.

What is the NDC code for Eye Itch Relief .25 mg/mL?

The NDC (National Drug Code) for Eye Itch Relief .25 mg/mL is 36800-097, listed by TOPCO ASSOCIATES LLC.