FDA recall D-1698-2012

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-02-23

Report date

2012-10-03

Termination date

2018-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brewerton, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1698-2012