Why it was recalled
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Product description
SLIMFIT X capsules, packaged in a 60-cont bottle
Lot numbers, UPCs & expiration codes
All lots and all expiration dates.
Where it was sold
New Jersey and Maryland.
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-0473-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 9, 2016
- FDA report date
- Feb 22, 2017
- Quantity
- 150 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jersey Shore Supplements, LLC
Original FDA data
Every field from FDA enforcement report D-0473-2017, exactly as published.
Show all FDA fields
- City
- Bradley Beach
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75929
- Address
- 705 Brinley Ave
- Code information
- All lots and all expiration dates.
- Postal code
- 07720-1054
- Report date
- Feb 22, 2017
- Product type
- Drugs
- Recall number
- D-0473-2017
- Classification
- Class I
- Recalling firm
- Jersey Shore Supplements, LLC
- Product quantity
- 150 bottles
- Termination date
- Nov 17, 2020
- Reason for recall
- Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SLIMFIT X capsules, packaged in a 60-cont bottle
- Distribution pattern
- New Jersey and Maryland.
- Recall initiation date
- Dec 9, 2016
- Initial firm notification
- Center classification date
- Feb 13, 2017