Ultra Seal Corporation recalls REMfresh Advanced Ion-Powered Melatonin 5mg caplets due to cGMP deviations. Products with lot numbers 19B011, 19B012, 19B012A, 19E023 and expiration 05/2022 are affected.
cGMP deviations
Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin 5mg caplets because of cGMP deviations. This means the product may not meet quality standards, though the specific risk is not detailed in the recall.
The recall is due to cGMP deviations, which are quality control issues in manufacturing. These deviations could mean the product does not meet the required safety and quality standards, but the specific hazard is not described in the recall notice.
People who purchased the REMfresh Melatonin caplets with lot numbers 19B011, 19B012, 19B012A, or 19E023 from the specified expiration date are affected. Those using melatonin for sleep may be at risk if the product does not meet quality standards.
Check the lot number on the packaging, which should be 19B011, 19B012, 19B012A, or 19E023. The product expires by May 2022 and is sold by Ultra Seal Corporation in Boca Raton, Florida.
Look for lot numbers 19B011, 19B012, 19B012A, or 19E023 on the packaging.
The recall is due to cGMP deviations, which are quality control issues in manufacturing.
The recall notice does not specify a remedy, so check the lot number and contact Ultra Seal Corporation if you have the affected products.
The recall does not describe a specific hazard mechanism, so the risk 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-0517-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0517-2022 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.
