Bethel 30 capsules recalled for undeclared active ingredients
Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules because FDA analysis found undeclared sibutramine and phenolphthalein, making the product an unapproved new drug.
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 agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules, packaged in 30 count bottles and distributed by BETHEL INC. in New York, New York. The recall involves 18,678 bottles with Lot # 120514 and an expiration date of 12/2014. The product was distributed nationwide and was also available for sale via the internet.
The recall was initiated because FDA analysis found the product contained undeclared sibutramine and phenolphthalein. These are active ingredients that were once marketed in the U.S. but were removed due to safety reasons. Consequently, the product is considered an unapproved new drug marketed without an approved NDA/ANDA.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
- Manufacturer
- Bethel Nutritional Consulting, Inc
- Category
- Drug — Dietary Supplement
- Affected units
- 18,678
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 #: 120514
- EXP: 12/2014
Distribution
Distributed nationwide across the United States.
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