Health One Pharmaceuticals Recalls Mammo-Guard Dietary Supplements
Health One Pharmaceuticals is recalling Mammo-Guard dietary supplements due to significant violations of current good manufacturing practices (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 rubric for moderate severity involving regulatory non-compliance without reported specific acute hazards like pathogens or injuries.
Plain-English summary
Health One Pharmaceuticals is voluntarily recalling 2,497 units of Mammo-Guard dietary supplements. The recall was initiated because the product was found to have significant violations of the current good manufacturing practices (cGMP) regulations for dietary supplements.
The affected products were distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho. Additionally, the products were distributed internationally in Hong Kong, Vietnam, China, and Singapore. The specific code information associated with the recalled units is 8861.
Consumers who have purchased Mammo-Guard 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
- Mammo-Guard
- Manufacturer
- Health One Pharmaceuticals Inc
- Category
- Food — Dietary Supplements
- Hazard
- Affected units
- 2,497
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)
- 8861
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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