The Recall Desk

FDA (Drugs) recall action 65894

Bethel Nutritional Consulting, Inc recalled 2 products on 2013-12-25

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-12-25
Critical
1
Units
22,387

Why these products were recalled

Marketed Without An Approved NDA/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.

Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2013-12-25

    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.

    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.
    Category
    Distribution
    1 state
  • CriticalFDA (Drugs)··2013-12-25

    Quick Thin capsules recalled for containing unapproved drugs

    Bethel Nutritional Consulting is recalling Quick Thin capsules because FDA analysis detected unapproved drugs sibutramine and phenolphthalein.

    Product
    Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.
    Category
    Distribution
    1 state