Ultra Seal Corporation recalls PAINA: 2 caplet packets of premenstrual formula with acetaminophen 500mg and pamabrom 25mg due to cGMP deviations. No remedy specified in official notice.
cGMP deviations
Ultra Seal Corporation is recalling PAINAID PMF Premenstrual Formula (2 caplet packets) because of manufacturing quality control issues. This recall does not include a specific remedy or action for consumers.
The product was manufactured with cGMP (current Good Manufacturing Practice) deviations, which means the quality control process failed. This could lead to inconsistent dosing or safety issues, but the exact risk is not specified in the recall notice.
Women who purchased the PAINAID PMF Premenstrual Formula 2 caplet packets from ZEE Medical Distributors, LLC in Mason, OH. Those with the specific lot numbers and expiration date are most at risk.
Check for the product name 'PAINAID PMF Premenstrual Formula' with 2 caplet packets. Look for the lot numbers AK9434, (L)101, and expiration date 01/2022. The product was distributed by ZEE Medical Distributors, LLC in Mason, OH.
Identify the product by checking the lot number (AK9434, (L)101) and expiration date (01/2022) on the packaging.
The official recall notice does not specify any remedy for this product.
The product was manufactured with cGMP deviations, which means the quality control process failed.
Check for the product name 'PAINAID PMF Premenstrual Formula' with 2 caplet packets, lot numbers AK9434 or (L)101, and expiration date 01/2022.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0494-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0494-2022 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.
