Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination
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.
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
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.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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.
If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found athttps://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm and following the instructions for emailing the completed form to FDA.
If you have a question about ADE reporting or need a paper copy of the form, contact CVM by email at AskCVM@fda.hhs.gov or by phone at 1-888-FDA-VETS (1-888-332-8387).