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
New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street Bronx, NY 10468, 316 Monroe Street Passaic, NJ 07055 and 200 Dyckman Street New York, NY 10040.
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-0315-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 25, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 14 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New Life Nutritional Center
Original FDA data
Every field from FDA enforcement report D-0315-2015, 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-0315-2015
- Classification
- Class I
- Recalling firm
- New Life Nutritional Center
- Product quantity
- 14 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
- New Life Nutritional SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font. Distributed by: New Life Nutritional under the following addresses: 714 West 181st Street New York, NY 10033, 153 East 188th Street Bronx, NY 10468, 316 Monroe Street Passaic, NJ 07055 and 200 Dyckman Street New York, NY 10040.
- 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