RemedyRepack Inc. recalls Ketotifen Fumarate 0.025% eye drops due to quality program discontinuation. Affected units may not meet safety standards. Consumers should check NDC and lot numbers 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.
RemedyRepack Inc. is recalling Ketotifen Fumarate 0.025% eye drops because the manufacturer discontinued their quality assurance program. This could mean the product doesn't meet safety standards, but the recall doesn't specify immediate harm risks.
The manufacturer discontinued their quality program, which means the product might not meet the required safety and quality standards. This could lead to the product not being as effective or safe as it should be, but the recall doesn't specify how this affects users.
People who own or use Ketotifen Fumarate 0.025% eye drops with the specific NDC and lot numbers listed are affected. Those using the product for eye allergies may be at risk if the quality program was discontinued.
Check for the NDC number 70518-1142-00 and lot numbers B1643789-041022 (expiring 03/31/2024) or B1894150-100722/B1891573-100622 (expiring 07/31/2024). The product was repackaged by RemedyRepack Inc. in Indiana, PA.
Identify the NDC number 70518-1142-00 and lot numbers listed in the recall notice to confirm if your product is affected.
The recall states the manufacturer discontinued their quality program, but it does not specify if the product is unsafe. Consumers should check the recall details to confirm.
Check for the NDC number 70518-1142-00 and lot numbers B1643789-041022 (expiring 03/31/2024) or B1894150-100722/B1891573-100622 (expiring 07/31/2024).
The recall does not specify a remedy, so consumers should check the product details to see if it matches the affected items listed.
We’ve drafted a message you can send RemedyRepack to request your refund or repair — edit it as you like.
Subject: Recall D-0577-2023 — RemedyRepack RemedyRepack Hello, I own a RemedyRepack that is covered by recall D-0577-2023 from RemedyRepack. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
