The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-2261-2014·Announced 2014-08-06

GM Manufacturing Recalls Rinozan Dietary Supplements for cGMP Violations

GM Manufacturing is recalling Rinozan dietary supplements due to significant violations of current Good Manufacturing Practice (cGMP) regulations.

The agency’s classification

FDA (Food): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 cGMP violations without reported illnesses or specific acute hazards like allergens or pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GM Manufacturing Inc. is voluntarily recalling Rinozan, 250cc HDPE Bottles, a dietary supplement. 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 recall involves 501 units of the product. The affected units have an expiration date of 09.2016. The product was distributed in California (CA).

Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions or a refund.

The recalled product

Product
Rinozan, 250cc HDPE Bottles
Affected units
501

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)

  • EXP09.2016

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 46 recalled by GM Manufacturing 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 46 products in this recall →

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