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REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters P...

FDA Recall #D-0517-2022 — Class II — January 24, 2022

Recall #D-0517-2022 Date: January 24, 2022 Classification: Class II Status: Terminated

Product Description

REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487

Reason for Recall

cGMP deviations

Recalling Firm

Ultra Seal Corporation — New Paltz, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

40,344 blisters

Distribution

Nationwide within the United States

Code Information

Lot #: 19B011, 19B012, 19B012A, 19E023, Exp. Date 05/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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