Ultra Seal recalls CETAFEN cough and cold relief tablets due to cGMP deviations. Affected lots were manufactured for HARTHealth in Seattle, WA. Consumers should check product details and contact Ultra Seal for guidance.
cGMP deviations
Ultra Seal Corporation is recalling CETAFEN cough and cold relief tablets because of cGMP deviations. This means the product may not meet quality standards, though the specific risk isn't detailed in the recall notice.
The recall is due to cGMP deviations, which are quality control issues in manufacturing. This could mean the product doesn't meet safety or quality standards, but the specific hazard isn't described in the notice.
People who own or use CETAFEN cough and cold relief tablets with the lot number AK9841 manufactured for HARTHealth in Seattle, WA. Those most at risk are individuals using the product for cold or cough symptoms.
Check for the product name 'CETAFEN COUGH & COLD RELIEF' on the packaging. Look for the lot number AK9841 and the expiration date of 10/2022. The product was manufactured for HARTHealth in Seattle, WA.
Look for the lot number AK9841 and expiration date 10/2022 on the packaging.
The recall is due to cGMP deviations, which are quality control issues in manufacturing. The specific risk isn't detailed in the notice.
Check for the product name 'CETAFEN COUGH & COLD RELIEF' with lot number AK9841 and expiration date 10/2022.
The recall notice does not specify a remedy, so contact Ultra Seal Corporation for guidance.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0510-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0510-2022 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.