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COMPANY ANNOUNCEMENT

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin Due to Possible Microbial Contamination

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin Due to Possible Microbial Contamination

Summary

Company Announcement Date:
August 29, 2018
FDA Publish Date:
August 29, 2018
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Due to Possible Microbial Contamination
Company Name:
HelloLife, Inc.
Brand Name:
Brand Name(s)
Neuroveen, Respitrol, Thyroveev, Compulsin
Product Description:
Product Description
Homeopathic Medicines

Company Announcement

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia.

Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table below) that were manufactured at the King Bio, Inc facility in Asheville, NC.

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. To date, HelloLife, Inc. has not received any reports of adverse events related to the recalled products.

Specific information is as follows, all products are packaged into 2 ounce amber bottles:

PRODUCT INDICATION NDC UPC LOT EXP. DATE
Neuroveen Natural temporary relief for nerve pain symptoms 49726-
015-02
891129002804 NV/030717D 07/19
Respitrol Natural temporary relief for respiratory symptoms 49726-
003-02
891129002729 RE/030717E 07/19
Thyroveev Natural temporary relief for sluggish thyroid symptoms 49726-
025-02
349726000063 TVV/030717F 07/19
Compulsin Nervous, repetitive thought/behavior relief 49726-
034-02
891129002194 CO/030717B 07/19

These products can be identified by the main label on the bottle and the lot number that is printed on the label. Product was distributed worldwide via wholesale, retail and online sales.

HelloLife, Inc. is notifying its distributors and customers by email, phone calls and written letters sent via the postal service and is arranging for replacement products where available and/or refunds. Consumers, retailers and wholesalers that have product, which is being recalled, should stop use immediately and remove all inventory from sales and contact HelloLife, Inc. to arrange for disposal and product replacement or refunds.

Consumers with questions regarding this recall can contact HelloLife, Inc. by calling 1-616-803- 7243 Monday-Friday 9:00 a.m. to 5:00 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program wither online, by regular mail or by fax. FDA contact instructions are:

This recall is being conducted with the knowledge of and in cooperation with the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
HelloLife, Inc.
1-616-803- 7243

Product Photos