Why it was recalled
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Product description
Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL
Lot numbers, UPCs & expiration codes
ALL LOTS
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-1378-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 24, 2014
- FDA report date
- Jun 18, 2014
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MyNicNaxs, Inc.
Original FDA data
Every field from FDA enforcement report D-1378-2014, exactly as published.
Show all FDA fields
- City
- Deltona
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 67471
- Address
- 1012 Alpine Dr
- Code information
- ALL LOTS
- Postal code
- 32725-7204
- Report date
- Jun 18, 2014
- Product type
- Drugs
- Recall number
- D-1378-2014
- Classification
- Class I
- Recalling firm
- MyNicNaxs, Inc.
- Product quantity
- unknown
- Termination date
- Oct 2, 2019
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 24, 2014
- Initial firm notification
- Center classification date
- Jun 12, 2014