Drug recall D-0577-2023

Class II Ongoing reported May 24, 2023

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;

Reason for recall

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.

Lots and codes

Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024

Recall details

Recalling firm
RemedyRepack Inc., Indiana, PA
Quantity
12 5mL bottles
Distribution
Product was distrituded to three direct account in PA.
Type
Voluntary: Firm initiated
Recall initiated
May 1, 2023