D-326-2013 Class I Terminated
FDA drug recall D-326-2013 was initiated by InSo-Independent Contractor for West Coast Nutritionals,LTD on May 18, 2012 and is designated Class I. 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 product… The recall status is terminated (terminated August 27, 2015). Affected quantity: 8,000 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- May 18, 2012
- Termination Date
- August 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,000 blister packs
Product Description
Reason for Recall
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.