Ultra Seal recalls CETAFEN Extra Non-Aspirin Pain Relieve caplets due to cGMP deviations. These 2-count packets, manufactured for HARTHealth, may have quality issues.
cGMP deviations
Ultra Seal is recalling CETAFEN Extra Non-Aspirin Pain Relieve caplets (2-count packets) because of manufacturing quality issues. This recall is due to cGMP deviations, which could affect product safety.
The product was manufactured under cGMP (Current Good Manufacturing Practice) deviations, which are quality control issues. This could mean the product may not meet safety standards, but the recall does not specify a direct risk of injury.
People who purchased CETAFEN Extra Non-Aspirin Pain Relieve caplets (2-count packets) from HARTHealth in Seattle, WA. Those most at risk are individuals using the product for pain relief.
Check for CETAFEN Extra Non-Aspirin Pain Relieve caplets in 2-count packets with lot number AK9475, manufactured for HARTHealth in Seattle, WA. The expiration date is February 2022.
Look for the lot number AK9475 and expiration date 02/2022 on the packaging.
The recall states there were cGMP deviations, but does not specify a direct risk of injury. The product may not meet safety standards.
The recall does not provide a specific remedy, so no action is required beyond checking the product details.
Check for CETAFEN Extra Non-Aspirin Pain Relieve caplets in 2-count packets with lot number AK9475, manufactured for HARTHealth in Seattle, WA.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0511-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0511-2022 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.
