FDAFDA · Food and drugs·Recall number D-0516-2022
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
Published February 9, 2022 · Recall initiated: January 24, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultra Seal Corporation
- Distributor
- Nationwide within the United States
- Lot
- Lot #: a) 19B050A, 19B050B, 19B050C, 19B050D, 19B050E, Exp. Date 06/2022; 19F063, 19F063A, 19F063B, Exp. Date 08/2022; b) 19B050-A, Exp. Date 06/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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