Ultra Seal Corporation recalls SINU-PHEN PLUS sinus pain and congestion tabs due to cGMP deviations. Affected products include 2-tablet packets with NDC 69103-2536-00, lot AK976: 08/2022 expiration.
cGMP deviations
Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets because of manufacturing quality control issues. This recall affects specific batches that may have safety risks due to improper production standards.
The recall is due to cGMP deviations, which means the manufacturing process did not meet quality control standards. This could potentially lead to unsafe product quality, though the exact risk is not specified in the recall notice.
People who purchased SINU-PHEN PLUS sinus pain and congestion tablets from Tellus Medical Products in Palm Desert, CA. Those with the specific lot number AK9766 and expiration date 08/2022 are most at risk.
Check for SINU-PHEN PLUS sinus pain and congestion tablets with NDC 69103-2536-00, lot number AK9766, and expiration date 08/2022. The product was manufactured by Tellus Medical Products in Palm Desert, CA.
Look for the NDC code 69103-2536-00, lot number AK9766, and expiration date 08/2022 on the packaging.
The recall is due to cGMP deviations, which means the manufacturing process did not meet quality control standards.
The recall notice does not specify a remedy, so check the product details to see if it matches the affected batch and contact Ultra Seal Corporation for further instructions.
The recall notice does not describe a specific hazard mechanism, so the risk 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-0489-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0489-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
