Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

For Immediate Release

October 3, 2018

Contact

Consumers

Nativeremedies@silverstarbrands.com
1-888- 736-6389

Announcement

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with  lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals and animals. To date, Silver Star Brands, Inc. has not received any reports of adverse events related to this recall.

These products can be identified by the main label on the bottle and the lot number that is printed on the label. Each product recalled is an individual 2 oz. oral spray in amber bottle (see table below), manufactured at the King Bio, Inc. facility in Asheville, NC.  Product was distributed nationwide via wholesale, retail and online sales.  Native Remedies®, PetAlive® and Healthful Naturals™ package images for products affected are attached (below).

HUMAN PRODUCTS
PRODUCTINDICATIONNDCUPCLOTEXPIRATION DATE
Native Remedies VertiFree oral sprayTemporary relief for dizziness and nausea68703-253-02818837012260K061417B6/20
Native Remedies VaricoGo oral sprayRelieves discomfort associated with varicose veins68703-105- 59818837010419K111717A11/20
Native Remedies HypoSlim oral sprayAssists with healthy weight management and metabolism68703-275- 02818837013724K051818A05/21
Native Remedies EyeClear Pro oral sprayRelieves symptoms of mineral buildup and eye irritation68703-151- 59818837011652K022317A, K022317B02/20
Healthful Naturals DizziFree oral sprayTemporarily relieves dizziness and nausea68703-204- 02840853166535K022616DN/A
Healthful Naturals Leg Cramp SupportTemporary relief from cramps and spasms while resting68703-206- 02840853166559K022216CN/A
PET PRODUCTS
PRODUCTINDICATIONNDCUPCLOTEXPIRATION DATE
PetAlive Plump-Up Pet oral sprayImproves appetite in underweight dogs and cats68703-290- 02818837013908K011617E01/20
PetAlive Allergy Itch Ease oral sprayRelieves skin itch68703-135- 59818837011102K111617B11/20

 Silver Star Brands, Inc. is notifying its distributors and customers by letter and is arranging for return and replacement (or refund) of the recalled products.

Consumers/distributors/retailers that have this product which is being recalled should discontinue use/distribution and contact Silver Star Brands, Inc.
at Nativeremedies@silverstarbrands.com to make arrangements to return the product. These
products were distributed nationwide to retailers (doctor offices, pharmacies, health food stores) and consumers (direct sales and website).

Consumers with questions regarding this recall can contact Silver Star Brands, Inc. at 1-888- 736-6389 Monday – Friday 8:00 am – 5:00 pm CST or email Nativeremedies@silverstarbrands.com. Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

The Center for Veterinary Medicine recommends calling the drug company to report adverse drug experiences or product defects for FDA-approved animal products. The drug company responsible for the approved product is required to submit these reports to FDA. Call1-888-736- 6389.

 

 

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Product Photos

Homeopathic Formula, Native Remedies VertiFree, ORAL SPRAY, 2 fl oz (59 mL)

Homeopathic Formula, Native Remedies VaricoGo, ORAL SPRAY, 2 fl oz (59 mL)

Homeopathic Formula, Native Remedies HypoSlim, ORAL SPRAY, 2 fl oz (59 mL)

Homeopathic Formula, Native Remedies EyeClear Pro, ORAL SPRAY, 2 fl oz (59 mL)

Homeopathic Formula, Healthful Naturals DizziFree, 2 fl oz (59 mL)

Homeopathic Formula, Healthful Naturals, Leg Cramp Support, 2 fl oz (59 mL)

Homeopathic Formula, PetAlive, Plump-Up Pet, ORAL SPRAY, 2 fl oz (59 mL)

Homeopathic Formula, PetAlive, Allergy Itch Ease, ORAL SPRAY, 2 FL OZ (59 mL)

Page Last Updated: 10/04/2018
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