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| The United States: Silver Star Brands, Inc. issues voluntary nationwide recall of human and animal drug products due to microbial contamination (English Only) |
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The US Food and Drug Administration (FDA) announces that 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 to the consumer level. The products have been tested and found to contain microbial contamination. The affected products are:
- Native Remedies VertiFree oral spray (Lot: K061417B; Expiration Date: 6/20)
- Native Remedies VaricoGo oral spray (Lot: K111717A; Expiration Date: 11/20)
- Native Remedies HypoSlim oral spray (Lot: K051818A; Expiration Date: 05/21)
- Native Remedies EyeClear Pro oral spray (Lot: K022317A, K022317B; Expiration Date: 02/20)
- Healthful Naturals DizziFree oral spray (Lot: K022616D; Expiration Date: N/A)
- Healthful Naturals Leg Cramp Support (Lot: K022216C; Expiration Date: N/A)
- PetAlive Plump-Up Pet oral spray (Lot: K011617E; Expiration Date: 01/20)
- PetAlive Allergy Itch Ease oral spray (Lot: K111617B; Expiration Date: 11/20)
Each product recalled is an individual 2 oz. oral spray in amber bottle, manufactured at the King Bio, Inc. facility in Asheville, NC. Product was distributed nationwide via wholesale, retail and online sales.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm622488.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news on products by King Bio Inc. was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 21 Jul 2018, with the latest update posted on 21 Sep 2018.
Ends/Friday, Oct 5, 2018
Issued at HKT 15:00
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