The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0970-2016·Announced 2016-06-15

FDA Recalls Asia Black 25 Ephedra Extreme Fat Burner for Unapproved Ingredients

Novacare, LLC is recalling Asia Black 25 Ephedra Extreme Fat Burner because FDA sampling confirmed the presence of salicylic acid, an unapproved ingredient in dietary supplements.

The agency’s classification

FDA (Drugs): 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 source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Novacare, LLC is recalling Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement, packaged in 100 capsule containers. The product is distributed by Cloma Pharma Laboratories in Samford, CT, and was distributed nationwide. The recall is identified by UPC 859613274229.

The U.S. Food and Drug Administration (FDA) initiated this recall because FDA sampling confirmed the presence of salicylic acid in the dietary supplement. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA has classified this recall as Class I.

Consumers who have purchased this product should stop using it immediately. The source text does not provide specific instructions for disposal or return, but consumers should generally follow the guidance provided by the recalling firm or the FDA regarding the handling of recalled dietary supplements.

The recalled product

Product
Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Manufacturer
Novacare, LLC
Category
Drug — Dietary Supplement
Hazard

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)

  • UPC 859613274229

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Novacare, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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