The Recall Desk
ModerateFDA (Food)·F-1683-2015·Announced 2015-04-08

Health One Pharmaceuticals Recalls SOD Herbal Mix for cGMP Violations

Health One Pharmaceuticals is recalling SOD Herbal Mix 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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Health One Pharmaceuticals is voluntarily recalling SOD Herbal Mix dietary supplements. The recall was initiated because the product was found to have significant violations of the current Good Manufacturing Practice (cGMP) regulations for dietary supplements.

The affected product is SOD Herbal Mix, manufactured by Health One Pharmaceuticals Inc. The recall involves 17,000 units. The product was distributed nationwide in the United States, specifically in California, Tennessee, Washington, and Idaho, as well as internationally in Hong Kong, Vietnam, China, and Singapore. The specific code information associated with the recall is 8939.

Consumers who have purchased SOD Herbal Mix should stop using the product and contact Health One Pharmaceuticals for further instructions or a refund. This recall is classified as Class II by the U.S. Food and Drug Administration, indicating that the violation is unlikely to cause serious adverse health consequences or death, but may cause temporary or medically reversible health consequences.

The recalled product

Product
SOD Herbal Mix
Manufacturer
Health One Pharmaceuticals Inc
Category
Food — Dietary Supplement
Hazard
Affected units
17,000

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)

  • 8939

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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.

See all 147 products in this recall →

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