SLIM-K Capsules Recalled for Unapproved Dangerous Ingredients
Bethel Nutritional Consulting is recalling SLIM-K capsules because FDA testing found unapproved ingredients including sibutramine and phenolphthalein.
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 recall is classified as FDA Class I, which meets the criteria for a Critical severity score.
Plain-English summary
Bethel Nutritional Consulting, Inc. is recalling SLIM-K, 30 Capsules, distributed by Bethel Inc. The product was found to contain sibutramine, desmethylsibutramine, and phenolphthalein based on FDA sampling and analysis. These ingredients were not approved for use in the product, which was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death. The affected product is identified by Lot # 140430 and an expiration date of 12/17. The barcode is 160126417509.
Consumers who have purchased this product should stop using it immediately and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
- Manufacturer
- Bethel Nutritional Consulting, Inc
- Category
- Drug — Dietary Supplement
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 (2)
- Lot # 140430
- Exp.12/17
Distribution
Distributed nationwide across the United States.
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