The Recall Desk
Agency classClass IOur severity:CriticalFDA (Food)·F-2356-2012·Announced 2012-09-26

Hocean Recalls Nitre Powder Lacking Required Directions for Use

Hocean Inc is recalling Nitre powder because the label lacks required directions for use, which could lead to overuse and life-threatening health hazards.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, and the source text explicitly states that the hazard can be life-threatening.

Plain-English summary

Hocean Inc is voluntarily recalling 50 cases of Nitre powder, sold in 4-oz plastic bags under the brand "Selected Product". The product is identified by UPC 0 45027 97918 2. The recall was initiated on May 25, 2012, and includes all product on the market at that time, as the items do not bear manufacturing codes.

The FDA analysis determined that the product consisted mainly of sodium nitrite. The recall is due to a labeling violation: the product failed to bear adequate directions for use as required by 21 CFR 172.175. The FDA states that the failure to provide these directions may result in overuse, which can pose a life-threatening hazard to health.

The product was distributed to wholesale distributors and Asian grocery stores nationwide. Affected states include California, Texas, Oregon, Nebraska, Georgia, Florida, Colorado, Oklahoma, Washington, New Mexico, Ohio, Arizona, Tennessee, North Carolina, and Virginia. Consumers should stop using the product and return it to the place of purchase for a refund.

The recalled product

Product
Nitre powder. Brand "Selected Product", 4oz plastic bags, UPC 0 45027 97918 2.
Manufacturer
Hocean Inc

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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