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FDARecalled May 24, 2023 · #D-0577-2023

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...

Hazard

Class II — temporary health risk

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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. Classification: Class II Distribution: Product was distrituded to three direct account in PA.

Product details

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;
Type
Drugs
Manufacturer
RemedyRepack Inc.
Model numbers
B1643789-041022
UPCs