The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1201-2018·Announced 2018-09-19

FDA Recalls Neuroveen Homeopathic OTC Medicine for Microbial Contamination

The FDA is recalling Neuroveen Homeopathic OTC Medicine due to microbial contamination with Staphylococcus saprophyticus and Burkholderia cepacia.

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 FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle. The product is manufactured for HelloLife, Inc. The recall involves 4,358 bottles with lot number NV/030717D and an expiration date of 7/2019.

The recall is being conducted because the product is contaminated with microorganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The product was distributed nationwide in the United States and in numerous international locations, including Canada, the United Kingdom, and various countries in Europe, Asia, and South America. Consumers should stop using the product and contact their healthcare provider if they have any concerns.

The recalled product

Product
Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02
Manufacturer
Hellolife
Category
Drug — OTC Medicine
Hazard
Affected units
4,358

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 (2)

  • Lot: NV/030717D
  • exp 7/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Hellolife 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 4 products in this recall →

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