D-0317-2015 Class I Terminated
FDA drug recall D-0317-2015 was initiated by New Life Nutritional Center on March 25, 2014 and is designated Class I. 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… The recall status is terminated (terminated June 5, 2018). Affected quantity: 2 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- March 25, 2014
- Termination Date
- June 5, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 bottles
Product Description
Esmeralda, bottle contains 30 Softgels, product is packaged in a white plastic bottle with green labeling and black font. Distributed by: New Life Nutritional, www.newlifenutritional.com under the following addresses: 714 West 181st Street NY, NY 10033, 200-9 Dyckman Street NY, NY 10040, 153 East 188th Street Bronx, NY 10468 and 316 Monroe Street Passaic, NJ 07055.
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.
Distribution Pattern
NY, NJ, LA, TX, VA, MA
Code Information
no identifying lot numbers present