FDA Recall D-0317-2015
New Life Nutritional Center · New York, NY
Class I — life-threatening Terminated 1533 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0317-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- NY, NJ, LA, TX, VA, MA
- Recall initiated
- 2014-03-25
- Classified by FDA Center
- 2014-12-22
- FDA published
- 2014-12-31
- Terminated
- 2018-06-05
- Recalling firm
- New Life Nutritional Center
- Firm location
- New York, NY