Health One Pharmaceuticals Recalls Lutimax Dietary Supplements for cGMP Violations
Health One Pharmaceuticals is recalling Lutimax dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.
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 and involves significant cGMP violations, which fits the 'Moderate' criteria for voluntary precautionary recalls or minor regulatory issues without reported illness.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling Lutimax dietary supplements. The recall is being conducted because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.
The recalled product consists of 5,000 units of Lutimax. The distribution pattern includes nationwide distribution in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as international distribution to Hong Kong, Vietnam, China, and Singapore. The product code associated with the recall is 2362.
Consumers who have purchased Lutimax dietary supplements should stop using the product and contact Health One Pharmaceuticals for further instructions or a refund. The recall is driven by manufacturing compliance issues rather than a specific reported contamination or illness.
The recalled product
- Product
- Lutimax
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 5,000
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 (1)
- 2362
Distribution
Part of a larger recall action
This product is one of 147 recalled by Health One Pharmaceuticals Inc under a single FDA (Food) 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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