PlainRecalls
FDA Drug Moderate Class II Ongoing

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;

Reported: May 24, 2023 Initiated: May 1, 2023 #D-0577-2023

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;

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.

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
12 5mL bottles
Distribution
Product was distrituded to three direct account in PA.
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
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;. Recalled by RemedyRepack Inc.. Units affected: 12 5mL bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 24, 2023. Severity: Moderate. Recall number: D-0577-2023.