Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Product description
SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
Lot numbers, UPCs & expiration codes
Lot # 140430; Exp.12/17
Where it was sold
Nationwide
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-1207-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 19, 2014
- FDA report date
- Jul 15, 2015
- Quantity
- UNKNOWN
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bethel Nutritional Consulting, Inc
Original FDA data
Every field from FDA enforcement report D-1207-2015, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 70089
- Address
- 599 W 190th St Ste 1
- Code information
- Lot # 140430; Exp.12/17
- Postal code
- 10040-3577
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1207-2015
- Classification
- Class I
- Recalling firm
- Bethel Nutritional Consulting, Inc
- Product quantity
- UNKNOWN
- Termination date
- Jun 27, 2018
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 19, 2014
- Initial firm notification
- Press Release
- Center classification date
- Jul 6, 2015