FDA recall D-373-2014

Product

B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.

Distribution

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).

Key facts

Status

Terminated

Initiation date

2013-07-31

Report date

2013-12-25

Termination date

2015-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deer Park, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-373-2014