FDAFDA · Food and drugs·Recall number 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 # 17477-0717-10;
Published May 24, 2023 · Recall initiated: May 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Product was distrituded to three direct account in PA.
- Lot
- Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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