Bethel Advance capsules recalled for unapproved drug ingredients
Bethel Nutritional Consulting is recalling Bethel Advance capsules because FDA analysis detected unapproved drug ingredients, including phenolphthalein and sibutramine.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Bethel Nutritional Consulting, Inc. is recalling 13,266 bottles of Bethel Advance capsules, 400 mg, 30-count bottles. The product was distributed nationwide, in Puerto Rico, and via internet sales. The specific lot affected is Lot 10092011, with an expiration date of 2014.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market, making these products unapproved new drugs.
Consumers should stop using the product and contact Bethel, Inc. at (212) 568-5330 for further instructions.
The recalled product
- Product
- Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
- Manufacturer
- Bethel Nutritional Consulting, Inc
- Category
- Drug — Dietary Supplement
- Affected units
- 13,266
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 10092011
- Exp 2014
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bethel Nutritional Consulting, Inc 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 2 products in this recall →Related recalls
Same manufacturer · Bethel Nutritional Consulting, Inc
See all →- CriticalSLIM-K Capsules Recalled for Unapproved Dangerous Ingredients
FDA (Drugs) · 2015-07-15
- SevereB-Lipo Capsules Recalled for Containing Unapproved Controlled Substance Lorcaserin
FDA (Drugs) · 2015-04-01
- CriticalQuick Thin capsules recalled for containing unapproved drugs
FDA (Drugs) · 2013-12-25
- CriticalBethel 30 capsules recalled for undeclared active ingredients
FDA (Drugs) · 2013-09-04
Same hazard · unapproved drug ingredients
See all →- SevereImperia Elita Vitaccino Coffee Recalled for Unapproved Drug Ingredients
FDA (Drugs) · 2021-06-23
- CriticalBiotech Underground Tri-Ton Hardcore Formula Recalled for Unapproved Ingredients
FDA (Drugs) · 2017-08-23
- CriticalMS Bionic Recalls MegaJex Herbal Supplement Containing Unapproved ED Drugs
FDA (Drugs) · 2017-02-22
- CriticalFDA Recalls Virilis Pro Dietary Supplement for Unapproved Drug Ingredients
FDA (Drugs) · 2014-04-23