The Recall Desk
CriticalFDA (Drugs)·D-0149-2018·Announced 2018-01-10

FDA Recalls Unapproved Enhanced Vegetal Vigra Capsules Tainted with Sildenafil

Natures Supplement is recalling Enhanced Vegetal Vigra 200 mg capsules because FDA analysis found the product was tainted with Sildenafil and marketed without an approved NDA/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 per the rubric.

Plain-English summary

Natures Supplement is recalling 308 bottles of Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles. The product is identified by UPC# 8931028556885 and has an expiration date of 02/23/2020. All lots are affected.

The recall was initiated because the product was marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, FDA analysis determined that the product was tainted with Sildenafil, a prescription medication.

The affected product was distributed in Florida. Consumers who have purchased this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885
Manufacturer
Natures Supplement
Category
Drug — Unapproved Supplement
Hazard
Affected units
308

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 (2)

  • All lots
  • Exp. 02/23/2020

Distribution

Distributed in 1 state:

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