D1612-2014 Class I Terminated

Recalled by Eugene Oregon, Inc. — Levittown, PA

Recall Details

Product Type
Drugs
Report Date
October 8, 2014
Initiation Date
May 5, 2014
Termination Date
April 1, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
460 boxes

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: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Distribution Pattern

To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC

Code Information

All lots