FDA Recall D-265-2013

Body Basics Inc · Canoga Park, CA

Class I — life-threatening Terminated 534 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA

Lot / code: Lot number 008A, expiration date Dec 2014, UPC code 830733002016

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 record

Recall number: D-265-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Telephone
Distribution: Nationwide
Recall initiated: 2011-12-19
Classified by FDA Center: 2013-04-18
FDA published: 2013-04-24
Terminated: 2013-06-05
Recalling firm: Body Basics Inc
Firm location: Canoga Park, CA

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