RemedyRepack Inc. recalls Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: Remed
Recalled May 24, 2023 · FDA recall D-0577-2023 · RemedyRepack
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. · FDA Class II
Units
12 5mL bottles
Sold at
Product was distrituded to three direct account in PA.
Description
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.
Product
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;
Manufacturer(s)
RemedyRepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →