D-1596-2014 Class I Terminated

Recalled by Nova Products, Inc. — Aston, PA

Recall Details

Product Type
Drugs
Report Date
September 24, 2014
Initiation Date
March 28, 2014
Termination Date
August 6, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

Product Description

AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.

Reason for Recall

Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.

Distribution Pattern

Nationwide to retailers and distributors

Code Information

2006-000926