Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-1698-2012

February 23, 2012

Class I

Product summary

Firm
www.vitaminbestbuy.com
Event
Event 61256
Status
Terminated
Classification
Class I
Quantity
550 boxes
Official record key
drug-enforcement:D-1698-2012

Official wording

Reason: Marketed Without an Approved ANDA/NDA: presence of sildenafil

Code information: All lots.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved ANDA/NDA: presence of sildenafil