Ultra Seal Corporation recalls Cetafen non-aspirin pain relievers with acetaminophen 325mg due to cGMP deviations. Affected lots expired by June 2022.
cGMP deviations
Ultra Seal Corporation is recalling Cetafen non-aspirin pain relievers (acetaminophen 325mg) because of manufacturing deviations. This recall affects specific lots that expired by June 2022.
The product was made with cGMP (current Good Manufacturing Practice) deviations, which means the manufacturing process didn't meet quality standards. This could lead to potential safety issues with the medication.
People who purchased Cetafen pain relievers from HARTHealth Seattle in Washington state. Those who used the recalled lots are most at risk.
Check for the brand name 'Cetafen' and the lot numbers A-K-9668 (expiring June 2022) or A-K-9475 (expiring February 2022). The product was sold by HARTHealth Seattle in Washington.
Look for the lot numbers A-K-9668 (expiring June 2022) or A-K-9475 (expiring February 2022) on the packaging.
The product was made with cGMP deviations, which means the manufacturing process didn't meet quality standards.
Check for the lot numbers A-K-9668 (expiring June 2022) or A-K-9475 (expiring February 2022) on the packaging.
The recall record does not specify a remedy for this product.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0477-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0477-2022 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.
