Basic Reset Nuovi Skin Toner Recalled for Lack of FDA Approval
Basic Reset Inc. is recalling 1,000 bottles of Nuovi Skin Toner because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
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: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses.
Plain-English summary
Basic Reset Inc. is recalling 1,000 bottles of Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The affected product is distributed by Basic Reset in Hendersonville, TN. The recall covers lots 28917A, 23918A, and 21519A. The product was distributed in the United States (including Puerto Rico and U.S. Virgin Islands), Canada, Nigeria, the United Kingdom, Australia, Israel, Hungary, the UAE, Mexico, the Philippines, and Greece.
Consumers who have this product should stop using it and contact Basic Reset Inc. for further instructions.
The recalled product
- Product
- Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075
- Manufacturer
- Basic Reset Inc.
- Category
- Drug — Topical
- Hazard
- Affected units
- 1,000
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 (3)
- Lots: 28917A
- 23918A
- 21519A
Distribution
Part of a larger recall action
This product is one of 11 recalled by Basic Reset Inc. 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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