May 2012 FDA Recall Drug by Inso-independent Contractor For West Coast Nutritionals,ltd
D-326-2013 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Inso-independent Contractor For West Coast Nutritionals,ltd on May 18, 2012 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-326-2013

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.
Initiated
05-18-2012
Reported
05-22-2013
Quantity
8,000 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61900
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
InSo-Independent Contractor for West Coast Nutritionals,LTD
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
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.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-27-2015
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# All lots