Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-326-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 18, 2012
- FDA report date
- May 22, 2013
- Quantity
- 8,000 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InSo-Independent Contractor for West Coast Nutritionals,LTD
Original FDA data
Every field from FDA enforcement report D-326-2013, exactly as published.
Show all FDA fields
- City
- Allen
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 61900
- Address
- 404 Bastrop Dr
- Code information
- All lots
- Postal code
- 75013-4763
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-326-2013
- Classification
- Class I
- Recalling firm
- InSo-Independent Contractor for West Coast Nutritionals,LTD
- Product quantity
- 8,000 blister packs
- Termination date
- Aug 27, 2015
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- 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.
- Recall initiation date
- May 18, 2012
- Initial firm notification
- Press Release
- Center classification date
- May 16, 2013