D-374-2014 Class I Terminated
FDA drug recall D-374-2014 was initiated by Healthy Life Chemistry Inc dba Purity First on July 31, 2013 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug. The recall status is terminated (terminated May 11, 2015). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2013
- Initiation Date
- July 31, 2013
- Termination Date
- May 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
Reason for Recall
Distribution Pattern
Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS. Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).