FDA Recall D-1698-2012
www.vitaminbestbuy.com · Brewerton, NY
Class I — life-threatening Terminated 2443 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
Reason for recall
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Recall record
- Recall number
D-1698-2012- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2012-02-23
- Classified by FDA Center
- 2012-09-26
- FDA published
- 2012-10-03
- Terminated
- 2018-11-01
- Recalling firm
- www.vitaminbestbuy.com
- Firm location
- Brewerton, NY