a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule blister packs in a box, www.HotRodExtraStrength.com

Reason: Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.

Code information: All lots

Distribution pattern: Nationwide in the United States, U.S. Virgin Islands, Puerto Rico and to the following locations: United Kingdom, United Arab Emirates, Turkey, Trinidad & Tobago, Thailand, Taiwan, Sweden, St. Maarten, Spain, South Africa, Singapore, Saudi Arabia, Russia, Romania, Qatar, Portugal, Poland, Philippines, Papua New Guinea, Pakistan, Oman, Norway, Nigeria, New Zealand, Netherlands Antilles, Netherlands, Mozambique, Montenegro, Mauritius, Malta, Maldives, Malaysia, Latvia, Kuwait, South Korea, Jordan, Japan, Jamaica, Italy, Ireland, Iraq, India, Hong Kong, Guatemala, Greece, Germany, France, England, Denmark, Cyprus, Curacao, Congo, Cayman Islands, Canada, Australia, Belize, and Turks and Caicos Islands.