RemedyRepack Inc.: Drug Recall

Recall #D-0577-2023 · 05/01/2023

Class II: Risk

Recall Details

Recall Number
D-0577-2023
Classification
Class II
Product Type
Drug
Recalling Firm
RemedyRepack Inc.
Status
Ongoing
Date Initiated
05/01/2023
Location
Indiana, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 5mL bottles

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.

Product Description

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;

Distribution Pattern

Product was distrituded to three direct account in PA.

Other Recalls by RemedyRepack Inc.

View all recalls by RemedyRepack Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.