The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0254-2019·Announced 2018-11-14

Silver Star Brands Recalls Native Remedies EyeClear Pro Oral Spray

Silver Star Brands is recalling Native Remedies EyeClear Pro Oral Spray due to microbial contamination. Consumers should stop using the product and return it to the retailer.

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 text explicitly identifies the agency classification as 'Class I' for a drug product, which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

Silver Star Brands is voluntarily recalling 931 bottles of Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle. The product is distributed by Silver Star Brands in Oshkosh, Wisconsin, and carries the NDC 68703-151-59. The recall affects products with lot numbers K022317A and K022317B.

The recall was initiated because the non-sterile product was found to be microbially contaminated. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

The product was distributed nationwide in the United States. Consumers who have purchased this product should stop using it immediately and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59
Manufacturer
Silver Star Brands
Affected units
931

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 K022317A and K022317B

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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