Why it was recalled
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Product description
MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font. Distributed by: New Life nutritional, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188.
Lot numbers, UPCs & expiration codes
no identifying lot numbers present
Where it was sold
NY, NJ, LA, TX, VA, MA
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-0316-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 25, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 13 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New Life Nutritional Center
Original FDA data
Every field from FDA enforcement report D-0316-2015, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67807
- Address
- 714 W 181st St
- Code information
- no identifying lot numbers present
- Postal code
- 10033-4702
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0316-2015
- Classification
- Class I
- Recalling firm
- New Life Nutritional Center
- Product quantity
- 13 bottles
- Termination date
- Jun 5, 2018
- Reason for recall
- Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font. Distributed by: New Life nutritional, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188.
- Distribution pattern
- NY, NJ, LA, TX, VA, MA
- Recall initiation date
- Mar 25, 2014
- Initial firm notification
- Press Release
- Center classification date
- Dec 22, 2014