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

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*
PRODUCT	INDICATION	NDC	UPC	LOT	EXPIRATION DATE
Native Remedies VertiFree oral spray	Temporary relief for dizziness and nausea	68703-253-02	818837012260	K061417B	6/20
Native Remedies VaricoGo oral spray	Relieves discomfort associated with varicose veins	68703-105- 59	818837010419	K111717A	11/20
Native Remedies HypoSlim oral spray	Assists with healthy weight management and metabolism	68703-275- 02	818837013724	K051818A	05/21
Native Remedies EyeClear Pro oral spray	Relieves symptoms of mineral buildup and eye irritation	68703-151- 59	818837011652	K022317A, K022317B	02/20
Healthful Naturals DizziFree oral spray	Temporarily relieves dizziness and nausea	68703-204- 02	840853166535	K022616D	N/A
Healthful Naturals Leg Cramp Support	Temporary relief from cramps and spasms while resting	68703-206- 02	840853166559	K022216C	N/A

*PET PRODUCTS*
PRODUCT	INDICATION	NDC	UPC	LOT	EXPIRATION DATE
PetAlive Plump-Up Pet oral spray	Improves appetite in underweight dogs and cats	68703-290- 02	818837013908	K011617E	01/20
PetAlive Allergy Itch Ease oral spray	Relieves skin itch	68703-135- 59	818837011102	K111617B	11/20

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 [email protected] 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 [email protected]. 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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