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 initiated: 20120223
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated