Agency classClass IOur severity:Severe FDA (Drugs)·D-0968-2016·Announced 2016-06-15

Dietary Supplement Recalled for Unapproved Salicylic Acid Content

Novacare, LLC is recalling Thin and Slim Naturally AM dietary supplements because FDA sampling confirmed the presence of unapproved salicylic acid.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a score of 4 (Severe) or higher, and the presence of unapproved salicylic acid in a dietary supplement constitutes a significant health risk.

Plain-English summary

Novacare, LLC is recalling Thin and Slim Naturally The Natural Alternative AM Dietary Supplement, packaged in 90 capsule containers. The product is distributed by TSN Labs Inc. and was sold nationwide. The recall was initiated because FDA sampling confirmed the presence of salicylic acid in the dietary supplements.

The agency has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death. The source text notes that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers should stop using the product immediately. The specific UPC for the recalled product is 637687019003. Consumers may contact TSN Labs Inc. at 1-800-769-7290 or visit www.tsn2000.com for further information.

The recalled product

Product: Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
Manufacturer: Novacare, LLC
Category: Drug — Dietary Supplement
Hazard: unapproved-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 637687019003

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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Same hazard · unapproved ingredient