FDA-Drug2023-05-24Class II
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
RemedyRepack Inc.
Hazard
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.
Sold states
Product was distrituded to three direct account in PA.
Affected count
12 5mL bottles
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0577-2023Don't want to check this manually?
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