Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
Product description
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Lot numbers, UPCs & expiration codes
Lot #: 120514, EXP: 12/2014
Where it was sold
Nationwide. Product was also available for sale via internet
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-921-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 11, 2013
- FDA report date
- Sep 4, 2013
- Quantity
- 18,678 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bethel Nutritional Consulting, Inc
Original FDA data
Every field from FDA enforcement report D-921-2013, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65441
- Address
- 599 W 190th St Ste 1
- Code information
- Lot #: 120514, EXP: 12/2014
- Postal code
- 10040-3577
- Report date
- Sep 4, 2013
- Product type
- Drugs
- Recall number
- D-921-2013
- Classification
- Class I
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Product quantity
- 18,678 bottles
- Termination date
- Jun 27, 2018
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
- Distribution pattern
- Nationwide. Product was also available for sale via internet
- Recall initiation date
- Jun 11, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 23, 2013