Ultra Seal Corporation recalls PAPENOL (acetaminophen 500 mg) tablets due to cGMP deviations. Affected lots expired by February 2022.
cGMP deviations
Ultra Seal Corporation is recalling PAPENOL acetaminophen tablets because of manufacturing quality issues. This recall affects specific lots that expired by February 2022.
The recall is due to cGMP deviations, which are manufacturing quality issues that could affect product safety. However, the exact nature of the deviation is not specified in the notice.
People who purchased PAPENOL (acetaminophen 500 mg) tablets from Afassco Inc. in Minden, NV. Those with the specific lot numbers K9495 or AK9614 are most at risk.
Check for the lot numbers K9495 (expiring February 2022) or AK9614 (expiring May 2022) on the packaging. The product was manufactured for Afassco Inc. in Minden, NV.
Look for lot numbers K9495 or AK9614 on the packaging to identify affected items.
The recall is due to cGMP deviations, which are manufacturing quality issues. The exact nature of the deviation is not specified in the notice.
Check the lot number on the packaging. If it is K9495 or AK9614, contact Ultra Seal Corporation for further instructions.
The recall is for manufacturing quality issues, but the specific safety risks are not detailed in the notice.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0499-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0499-2022 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.
