Ultra Seal recalls Maximum Strength Non-Aspirin Pain Reliever (acetaminophen 50:000 mg) 2-tablet packets due to cGMP deviations. Consumers should check lot numbers and expiration dates.
cGMP deviations
Ultra Seal is recalling Maximum Strength Non-Aspirin Pain Reliever (acetaminophen 500 mg) 2-tablet packets because of manufacturing quality control issues. This recall affects products made for Advanced First Aid and American Safety & First Aid. The issue means the product may not meet safety standards, so it's important to stop using it if you have it.
The product was made with cGMP (current Good Manufacturing Practice) deviations, which means the manufacturing process did not follow safety and quality standards. This could lead to the product not being safe or effective, but the exact risk is not specified in the recall notice.
People who bought the Maximum Strength Non-Aspirin Pain Reliever (acetaminophen 500 mg) 2-tablet packets from Advanced First Aid in Baltimore or American Safety & First Aid in Osceola, IN. Those with the specific lot numbers AK9495 (expiring 02/2022) or AK9613 (expiring 05/2022) are most at risk.
Check the product label for the brand name Ultra Seal, product name Maximum Strength Non-Aspirin Pain Reliever, and the lot numbers AK9495 or AK9613. The expiration dates for these lots are February 2022 and May 2022, respectively.
Look for the lot numbers AK9495 or AK9613 on the product label.
The product was made with cGMP deviations, which means the manufacturing process did not follow safety and quality standards.
Check the product label for the lot numbers AK9495 or AK9613. If you have these lot numbers, stop using the product and contact the manufacturer for further instructions.
The recall notice does not specify the risk of serious injury, so the danger level is unknown.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0467-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0467-2022 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.
