KETOTIFEN FUMARATE .25 mg/mL
KETOTIFEN FUMARATE · SOLUTION · Unichem Pharmaceuticals (USA), Inc.
KETOTIFEN FUMARATE is a solution containing ketotifen fumarate at .25 mg/mL, taken ophthalmic. Manufactured by Unichem Pharmaceuticals (USA), Inc..
Key Facts
- Brand Name
- KETOTIFEN FUMARATE
- Generic Name
- KETOTIFEN FUMARATE
- NDC Code (Product)
76385-106- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Strength
- .25 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA204059
- Marketing Start
- 10/15/2021
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
RemedyRepack Inc.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Akorn, Inc.
CGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Frequently Asked Questions
What is KETOTIFEN FUMARATE used for?
KETOTIFEN FUMARATE contains KETOTIFEN FUMARATE. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is KETOTIFEN FUMARATE a controlled substance?
KETOTIFEN FUMARATE is not classified as a controlled substance by the DEA.
What is the generic name for KETOTIFEN FUMARATE?
The generic name for KETOTIFEN FUMARATE is KETOTIFEN FUMARATE. There are 11 other brand versions of KETOTIFEN FUMARATE.
What is the NDC code for KETOTIFEN FUMARATE .25 mg/mL?
The NDC (National Drug Code) for KETOTIFEN FUMARATE .25 mg/mL is 76385-106, listed by Unichem Pharmaceuticals (USA), Inc..
Other Ketotifen Brands
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- Eye Itch Relief.25 mg/mL21130-601
- Alaway.25 mg/mL24208-601
- Eye Itch Relief.25 mg/mL36800-097
- Eye Itch Relief.25 mg/mL50804-601
- Eye Itch Relief.25 mg/mL70000-0522
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)