Ultra Seal Corporation recalls PAINAID BRF Back Relief Formula tablets due to cGMP deviations. This may affect safety standards for medication production.
cGMP deviations
Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets because of manufacturing quality control issues. This recall does not indicate an immediate safety risk to consumers but requires action to ensure product safety standards.
The product was manufactured under cGMP (current Good Manufacturing Practices) deviations, which means the production process did not meet standard quality control requirements. This could potentially affect the consistency and safety of the medication, though the recall does not specify immediate harm.
People who purchased PAINAID BRF Back Relief Formula tablets from ZEE Medical Distributors, LLC in Mason, Ohio. Those with chronic pain conditions using this medication are most at risk.
Check for the product name 'PAINAID BRF Back Relief Formula' with 2 tablet packets. The lot number is AK9698 and expiration date is 07/2022. The product was distributed by ZEE Medical Distributors, LLC in Mason, Ohio.
Look for the lot number AK9698 and expiration date 07/2022 on the product packaging.
The recall is due to cGMP deviations, which may affect product consistency but does not indicate immediate safety risks. Consult your healthcare provider for guidance.
Check for the product name 'PAINAID BRF Back Relief Formula' with 2 tablet packets, lot number AK9698, and expiration date 07/2022.
The recall does not specify a remedy, so contact Ultra Seal Corporation for further instructions.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0493-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0493-2022 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.
