Ultra Seal Corporation recalls PAINAID 2-tablet packets due to cGMP deviations. Affected lots expired by January 2022 or August 2022. No remedy specified in official notice.
cGMP deviations
Ultra Seal Corporation is recalling PAINAID pain relief tablets that were manufactured with cGMP (current Good Manufacturing Practice) deviations. This means the product may not be safe or effective as intended, though the specific risk is not detailed in the recall notice.
The recall is for cGMP deviations, which are issues in how the product was made that could affect its safety or quality. However, the specific hazard (like contamination or incorrect dosage) is not clearly described in the notice. This makes it difficult to determine the exact risk.
People who purchased PAINAID 2-tablet packets from ZEE Medical Distributors in Mason, Ohio, with lot numbers AK9433 (expiring January 2022) or AK9749 (expiring August 2022) are affected. Those using the product for pain relief are most at risk due to potential safety issues.
Check for lot numbers AK9433 (expiring January 2022) or AK9749 (expiring August 2022) on the packaging. The product is sold by ZEE Medical Distributors in Mason, Ohio.
Look for lot numbers AK9433 or AK9749 on the packaging to identify affected items.
The official recall notice does not specify any remedy.
The recall mentions cGMP deviations, but does not clearly describe the specific hazard or risk.
Check for lot numbers AK9433 (expiring January 2022) or AK9749 (expiring August 2022) on the packaging.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0492-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0492-2022 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.
