REMfresh Advanced Ion-Powered Melatonin Caplets recalled over manufacturing violations
- Recall date
- January 24, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Ultra Seal Corporation recalls REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters…
- Recall number
- D-0516-2022
- FDA classification
- Class II
- Brand / firm
- Ultra Seal Corporation
- Sold / distributed
- Nationwide within the United States
Why it was recalled
cGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
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