FDA recall D1612-2014

Eugene Oregon, Inc. · Class I · drug

Product

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

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

Key facts

Status
Terminated
Initiation date
2014-05-05
Report date
2014-10-08
Termination date
2015-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D1612-2014