Why it was recalled
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Product description
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Lot numbers, UPCs & expiration codes
Lot number 008A, expiration date Dec 2014, UPC code 830733002016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-265-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 19, 2011
- FDA report date
- Apr 24, 2013
- Quantity
- 30,000 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Body Basics Inc
Original FDA data
Every field from FDA enforcement report D-265-2013, exactly as published.
Show all FDA fields
- City
- Canoga Park
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 62836
- Address
- 7334 Topanga Canyon Blvd Ste 119
- Code information
- Lot number 008A, expiration date Dec 2014, UPC code 830733002016
- Postal code
- 91303-3344
- Report date
- Apr 24, 2013
- Product type
- Drugs
- Recall number
- D-265-2013
- Classification
- Class I
- Recalling firm
- Body Basics Inc
- Product quantity
- 30,000 capsules
- Termination date
- Jun 5, 2013
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 19, 2011
- Initial firm notification
- Telephone
- Center classification date
- Apr 18, 2013