The Recall Desk
CriticalFDA (Drugs)·D-265-2013·Announced 2013-04-24

Body Basics Recalls Actra-SX Capsules Containing Unapproved Sildenafil

Body Basics Inc is recalling Actra-SX 500 capsules because they contain sildenafil, an active ingredient in FDA-approved erectile dysfunction drugs, without an approved NDA or ANDA.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Body Basics Inc is voluntarily recalling 30,000 capsules of Actra-SX 500 Capsules, Maximum Strength, Energizer. The product is sold in 5-count packages and was distributed nationwide. The specific lot number is 008A, with an expiration date of December 2014 and UPC code 830733002016.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules contain sildenafil, which is an active ingredient in FDA-approved products used to treat erectile dysfunction.

Consumers who have purchased this product should stop using it and contact Body Basics Inc for further instructions or a refund.

The recalled product

Product
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Manufacturer
Body Basics Inc
Category
Drug — Supplement
Hazard
Affected units
30,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot number 008A
  • expiration date Dec 2014
  • UPC code 830733002016

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · unapproved ingredient

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