Ultra Seal recalls Pain & Sinus Reliever nasal decongestant due to cGMP deviations. This product contains acetaminophen 50:000mg and phenylephrine HCl 5mg per 2 tablets.
cGMP deviations
Ultra Seal is recalling pain and sinus relief tablets that were made with cGMP deviations. This means the product may not be safe to use as intended.
cGMP deviations refer to failures in the manufacturing process that could lead to unsafe products. This product may not meet safety standards, but the specific risk is not clearly described in the recall notice.
People who bought this product from stores or online between the manufacturing date and expiration date are affected. Those with allergies to acetaminophen or phenylephrine should be extra cautious.
Check for the product name 'Pain & Sinus Reliever' with 2 tablet packets. Look for the lot number AK9527 and expiration date 03/2022 on the packaging.
Look for the lot number AK9527 and expiration date 03/2022 on the packaging to confirm if the product is recalled.
The recall states there were cGMP deviations, but does not specify if the product is unsafe. The manufacturer has not provided details on the specific risk.
The recall does not provide a remedy, so the official notice does not say what to do with the product.
Check for the product name 'Pain & Sinus Reliever' with 2 tablet packets, lot number AK9527, and expiration date 03/2022.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0497-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0497-2022 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.
