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Class I: serious health riskTerminated

Body Basics Actra-SX 500 Capsules Recall

Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basic…

Body Basics Inc · Canoga Park, CA

Risk level
Class I
Reported by FDA
Apr 24, 2013
Recall ID
D-265-2013
Check your lot numberHow we source this data

Summary

Body Basics recalled Actra-SX 500 Capsules starting Dec 19, 2011. The FDA classified it as Class I (serious health risk) and published enforcement report D-265-2013 on Apr 24, 2013. Reason: Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-265-2013, published Apr 24, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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