Silver Stars Brands, Inc. Issues Voluntary Nationwide Recall of Animal and Human Drug Products Due to Microbial Contamination
Company: Silver Star Brands, Inc.
Brand Name: PetAlive
Recall Date: 10/03/2018
PetAlive Plump-Up Pet oral spray (UPC: 818837013908)
Lot #: K011617E Expiration Date: 01/20
PetAlive Allergy Itch Ease oral spray (UPC: 818837011102)
Lot #: K111617B Expiration Date: 11/20
Reason for Recall:
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.
What to Do:
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. Call 1-888-736- 6389.
- If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found at https://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).
Source: FDA
