Why it was 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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot 10092011, Exp 2014
Where it was sold
Nationwide, Puerto Rico, and internet sales
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-372-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 5, 2013
- FDA report date
- Dec 25, 2013
- Quantity
- 13,266 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bethel Nutritional Consulting, Inc
Original FDA data
Every field from FDA enforcement report D-372-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65894
- Address
- 599 W 190th St Ste 1
- Code information
- Lot 10092011, Exp 2014
- Postal code
- 10040-3577
- Report date
- Dec 25, 2013
- Product type
- Drugs
- Recall number
- D-372-2014
- Classification
- Class I
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Product quantity
- 13,266 bottles
- Termination date
- May 30, 2018
- 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 phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide, Puerto Rico, and internet sales
- Recall initiation date
- Aug 5, 2013
- Initial firm notification
- Press Release
- Center classification date
- Dec 18, 2013