Drug recall
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut)…
FDA recall event 65894 · Class I · Bethel Nutritional Consulting, Inc
Key facts
| Event ID | 65894 |
|---|---|
| Recall numbers | D-371-2014, D-372-2014 |
| Recalling firm | Bethel Nutritional Consulting, Inc |
| Product type | Drugs |
| Products | 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…, 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)… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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…, Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug… |
| Initiation date | Aug 5, 2013 |
| Report date | Dec 25, 2013 |
| Termination date | May 30, 2018 |
| City | New York |
| State | NY |
| Country | United States |
| FEI number | 3010099772 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: