D-265-2013 Class I Terminated
FDA drug recall D-265-2013 was initiated by Body Basics Inc on December 19, 2011 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction The recall status is terminated (terminated June 5, 2013). Affected quantity: 30,000 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2013
- Initiation Date
- December 19, 2011
- Termination Date
- June 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,000 capsules
Product Description
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Reason for Recall
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Distribution Pattern
Nationwide
Code Information
Lot number 008A, expiration date Dec 2014, UPC code 830733002016