Drug product
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
D-265-2013
Product summary
- Firm
- Body Basics Inc
- Event
- Event 62836
- Status
- Terminated
- Classification
- Class I
- Quantity
- 30,000 capsules
- Official record key
drug-enforcement:D-265-2013
Official wording
Reason: Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Code information: Lot number 008A, expiration date Dec 2014, UPC code 830733002016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction