The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0253-2019·Announced 2018-11-14

Silver Star Brands Recalls Native Remedies VaricoGo Oral Spray Due to Microbial Contamination

Silver Star Brands is recalling 53 bottles of Native Remedies VaricoGo Oral Spray due to microbial contamination. The product was distributed nationwide in the United States.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).

Plain-English summary

Silver Star Brands, based in Oshkosh, Wisconsin, is recalling 53 bottles of Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle. The product is identified by NDC 68703-105-59 and Lot K111717A. The recall was initiated because the non-sterile product is subject to microbial contamination.

The affected product was distributed nationwide in the United States. The source text does not specify specific states or retail locations where the product was sold.

Consumers who have this product should stop using it and contact Silver Star Brands for further instructions or a refund. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59
Manufacturer
Silver Star Brands
Affected units
53

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot K111717A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Silver Star Brands under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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