REMfresh Advanced Ion-Powered Melatonin Caplets Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin 2 mg Caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 12-count and 36-count blister packages distributed across the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for manufacturing practice deviations without any reported illnesses or injuries. Per the rubric, Class II recalls without hospitalization reports or injury reports typically score 2 (Moderate). The hazard is procedural rather than acute.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets due to current Good Manufacturing Practice (cGMP) deviations. The affected products include 12-count blisters (lot numbers 19B050A, 19B050B, 19B050C, 19B050D, 19B050E with expiration date 06/2022; and lots 19F063, 19F063A, 19F063B with expiration date 08/2022) and 36-count blisters (lot number 19B050-A with expiration date 06/2022).
The products were distributed nationwide within the United States. The recall was initiated on January 24, 2022, and classified as a Class II recall by the FDA on January 31, 2022.
Consumers who have purchased this product should stop using it. Consumers with questions or concerns should contact their healthcare provider or pharmacist. The recall has been terminated as of October 16, 2023.
The recalled product
- Product
- 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
- Manufacturer
- Ultra Seal Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot #: a) 19B050A
- 19B050B
- 19B050C
- 19B050D
- 19B050E
- Exp. Date 06/2022
- 19F063
- 19F063A
- 19F063B
- Exp. Date 08/2022
- b) 19B050-A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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