Ultra Seal recalls cold tablets with cGMP deviations. These products may have quality issues affecting safety.
cGMP deviations
Ultra Seal Corporation is recalling cold tablets that contain acetaminophen, guaifenesin, and phenylephrine. The recall is due to cGMP deviations, which are quality control issues that could affect product safety.
cGMP deviations refer to quality control failures in manufacturing. This could mean the product has safety issues that might affect its effectiveness or safety.
People who bought these cold tablets from Respond Industries or American First Aid in Mason, OH. Those using the product for pain, fever, or cold symptoms are most at risk.
Look for cold tablets labeled with acetaminophen 325 mg, guaifenesin 200mg, and phenylephrine HCl 5 mg. They were manufactured by Respond Industries or American First Aid in Mason, OH, with lot number K9824 and expiration date 09/2022.
Verify the product label for acetaminophen 325 mg, guaifenesin 200mg, and phenylephrine HCl 5 mg.
The product was recalled due to cGMP deviations, which are quality control issues that could affect safety.
The recall record does not specify a remedy, so check the product details and contact the manufacturer if needed.
This product was sold by Respond Industries and American First Aid in Mason, OH.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0465-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0465-2022 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.
