D-1698-2012 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2012
- Initiation Date
- February 23, 2012
- Termination Date
- November 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 550 boxes
Product Description
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
Distribution Pattern
Nationwide
Code Information
All lots.