Agency classClass IOur severity:Critical FDA (Drugs)·D-0964-2016·Announced 2016-06-15

Novacare Recalls MetaPro 360 Supplement Containing Unapproved Salicylic Acid

Novacare, LLC is recalling MetaPro 360 Metabolic Accelerator dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug ingredient.

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 metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it represents a reasonable probability of serious adverse health consequences or death.

Plain-English summary

Novacare, LLC is recalling MetaPro 360 Metabolic Accelerator dietary supplements packaged in 120 capsule containers. The recall was initiated after FDA sampling confirmed the presence of salicylic acid in the product. Salicylic acid is a drug ingredient that was not approved for use in dietary supplements.

The affected product is identified by UPC 637687114593. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death. The product was distributed nationwide.

Consumers who have purchased MetaPro 360 Metabolic Accelerator should stop using the product immediately. They should contact Novacare, LLC at 877-778-7509 or visit www.metapro360.com for further instructions on how to return the product or obtain a refund.

The recalled product

Product: MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.
Manufacturer: Novacare, LLC
Category: Drug — Dietary Supplement
Hazard: unapproved-drug-ingredient
salicylic-acid

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 637687114593

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 →

Same manufacturer · Novacare, LLC

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