FDA recall D-1149-2014

Mira Health Products Ltd. · Class I · drug

Product

B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735

Reason for recall

Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-07-22
Report date
2014-03-12
Termination date
2014-09-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Farmingdale, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1149-2014