FDA Recall D-1613-2014
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
Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.
Reason for recall
Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain undeclared sildenafil.
Recall record
- Recall number
D-1613-2014- 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