Ultra Seal Corporation recalls CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets due to cGMP deviations. Affected lots expire 02/2022 and 09/2022.
cGMP deviations
Ultra Seal Corporation is recalling CONGESTAID II Nasal Decongestant tablets because of manufacturing quality control issues. This recall affects specific batches that expired by February 2022 and September 2022.
The product was made under cGMP (current Good Manufacturing Practice) deviations, which means the quality control process during production may not have met safety standards. This could potentially lead to unsafe levels of the active ingredient or contaminants in the product.
People who purchased CONGESTAID II Nasal Decongestant 2 tablet packets from ZEE Medical Distributors in Mason, OH between the specified lot dates are affected. Those using the product for nasal congestion relief are at risk.
Check for the product name 'CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets' with lot numbers AK9478 (expiring 02/2022) or AK9799 (expiring 09/2022).
Look for lot numbers AK9478 or AK9799 on the packaging to identify affected units.
The recall is due to cGMP deviations, which means the product may not meet safety standards. The manufacturer advises checking the lot number to determine if it's affected.
The recall record does not specify a remedy, so contact Ultra Seal Corporation directly for guidance on next steps.
Check the lot number on the packaging; affected units have lot numbers AK9478 (expiring 02/2022) or AK9799 (expiring 09/2022).
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0495-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0495-2022 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.
