REMfresh Advanced Ion-Powered Melatonin 2mg caplets with specific lot numbers recalled due to cGMP deviations. Consumers should contact the manufacturer for details.
cGMP deviations
Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin caplets (12-count and 36-count blister packs) because of cGMP deviations. This means the product may not meet safety standards, though the exact risk is not specified in the recall.
cGMP deviations refer to failures in manufacturing quality control processes. This could mean the product does not meet safety standards, but the exact hazard is not detailed in the recall notice.
People who purchased REMfresh Melatonin 2mg caplets with the listed lot numbers from the manufacturer's website or retail stores are affected. Those using the product for sleep aid are most at risk.
Check the blister pack for lot numbers: 19B050A-E (expiring 06/2022) or 19F063 (expiring 08/2022) for the 12-count packs, and 19B050-A (expiring 06/2022) for the 36-count packs.
Look for lot numbers on the blister pack: 19B050A-E (expiring 06/2022) or 19F063 (expiring 08/2022) for 12-count packs, and 19B050-A (expiring 06/2022) for 36-count packs.
The recall is due to cGMP deviations, which are failures in manufacturing quality control processes. The exact risk is not specified in the notice.
The recall notice does not specify a remedy, so contact Ultra Seal Corporation directly for instructions.
The recall states cGMP deviations, but the specific hazard is not detailed in the notice.
We’ve drafted a message you can send REMfresh to request your refund or repair — edit it as you like.
Subject: Recall D-0516-2022 — REMfresh REMfresh Hello, I own a REMfresh that is covered by recall D-0516-2022 from REMfresh. 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.
