Ultra Seal recalls cold/sinus pain reliever nasal decongestant due to cGMP deviations. Products contain acetaminophen 325mg and phenylephrine HCl 5mg. Check lot number K9708 from 07/2022.
cGMP deviations
Ultra Seal is recalling cold/sinus pain relievers that may have manufacturing quality issues. This could affect product safety, though the specific risk isn't detailed in the recall.
The recall mentions cGMP deviations, which are manufacturing quality issues. This could mean the product doesn't meet safety standards, but the exact risk isn't specified.
People who bought this nasal decongestant from Respond Industries or American First Aid in Mason, OH. Those using the product for cold/sinus symptoms are most at risk.
Check for the lot number K9708 on the packaging. Products were manufactured in Mason, OH by Respond Industries or American First Aid and expired by July 2022.
Look for the lot number K9708 on the packaging to confirm if your product is affected.
The recall states there were cGMP deviations, but does not specify if the product is unsafe. The manufacturer has not provided details on the risk.
The recall does not provide a remedy, so there is no action required beyond checking if your product has the lot number K9708.
The product was manufactured in Mason, OH by Respond Industries or American First Aid and expired by July 2022.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0486-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0486-2022 from Ultra Seal. 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.
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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.
