FDA Recall D1612-2014
Eugene Oregon, Inc. · Levittown, PA
Class I — life-threatening Terminated 331 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D1612-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- To retailers in MD, TX, FL, PA, IL, NJ, IN, LA, WA, ME, SC
- Recall initiated
- 2014-05-05
- Classified by FDA Center
- 2014-09-29
- FDA published
- 2014-10-08
- Terminated
- 2015-04-01
- Recalling firm
- Eugene Oregon, Inc.
- Firm location
- Levittown, PA