Ultra Seal Corporation recalls Cold Relief (acetaminophen 250mg, guaifenesin 200mg, phenylephrine HCl 5mg) due to cGMP deviations. Products manufactured for First Aid in Mason, OH with specific lot numbers and expiration dates are affected.
cGMP deviations
Ultra Seal Corporation is recalling Cold Relief cold medicine tablets that were made for First Aid in Mason, Ohio. The recall is due to cGMP (current good manufacturing practice) deviations, which means the product may not be safe or effective as intended.
The recall is for products that failed to meet current good manufacturing practices (cGMP). This means the product may not be safe or effective as intended. However, the exact risk to consumers is not clearly described in the recall notice.
People who own or use Cold Relief tablets with the specific lot numbers and expiration dates listed in the recall notice are affected. Those who have the product from the manufacturer in Mason, Ohio are most at risk.
Check the product label for the manufacturer's name 'Ultra Seal Corporation' and the lot numbers listed: K9456, AK9454, 9456, AK9456, AK9524, AK9528, K9767, AK9824, AK9823, AK9564. Also look for the expiration dates: January 2022, March 2022, August 2022, or September 2022.
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your product is affected.
The product was made for First Aid in Mason, Ohio and failed to meet current good manufacturing practices (cGMP), which means it may not be safe or effective as intended.
Check the product label for the specific lot numbers and expiration dates listed in the recall notice to see if it is affected. If it is, you should stop using it.
The recall notice does not mention any remedy or fix for this product.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0483-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0483-2022 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.
