Reported May 24, 2023 · Ongoing
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by:…
RemedyRepack Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RemedyRepack Inc. · 625 Kolter Dr Ste 4 · Indiana, PA · 15701-3571
Is this the product you have?
Ketotifen Fumarate 0.025 %Antihistamine eye drops5mL bottle
- MFGAkorn, Lake Forrest IL 60045
- Repackaged by
RemedyRepack IncIndianaPA 15701NDC 70518-1142-00Source NDC # 17477-0717-10
- Lot codes and dates
Lot # B1643789-041022EXP 03/31/2024B1894150-100722B1891573-100622EXP. 7/31/2024
- Amount recalled
- 12 5mL bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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