Status
Terminated
Drug Enforcement D-265-2013
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Classification
Class I
Report Date
April 24, 2013
Termination Date
June 5, 2013
Product Information
- Product description
- Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
- Product quantity
- 30,000 capsules
- 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
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Body Basics Inc
- Address
-
7334 Topanga Canyon Blvd Ste 119, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-265-2013
- Event ID
- 62836
- Recall initiation date
- December 19, 2011
- Center classification date
- April 18, 2013
- Code info
- Lot number 008A, expiration date Dec 2014, UPC code 830733002016
- More code info
- —