Drug Enforcement D-1698-2012

Marketed Without an Approved ANDA/NDA: presence of sildenafil

Status

Terminated

Classification

Class I

Report Date

October 3, 2012

Termination Date

November 1, 2018

Product Information

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
Product quantity
550 boxes
Reason for recall
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide

Location & Firm

Recalling firm
www.vitaminbestbuy.com
Address
6001 McKinley Rd., N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1698-2012
Event ID
61256
Recall initiation date
February 23, 2012
Center classification date
September 26, 2012
Code info
All lots.
More code info
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