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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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.
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