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COMPANY ANNOUNCEMENT

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to 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.

Read Announcement

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Summary

Company Announcement Date:
October 09, 2018
FDA Publish Date:
October 10, 2018
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Recall Reason Description
Possible microbial contamination
Company Name:
Eight and Company LLC, dba Sprayology
Brand Name:
Brand Name(s)
Sprayology
Product Description:
Product Description
Homeopathic Aqueous-Based Medicines

Company Announcement

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

RISK STATEMENT-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.

Eight and Company LLC, d/b/a Sprayology has not to date received any reports of adverse events related to this recall.

The products are for assorted symptom relief can be identified by the main label on the bottle and by the expiration date printed on the backside of the label. Each product recalled is an individual 1.38 oz. oral spray in white bottle manufactured at the King Bio, Inc. facility in Asheville, NC. Product was distributed nationwide via wholesale, retail and online sales. 

PRODUCT INDICATION NDC# LOT# Expirations
Rejuvenation Plus Energy 61096-0035-1 ALL 10/18-11/21
Man Power Sexual Support 61096-0025-1 ALL 10/18-1/22
Man Power Sexual support 61096-1025-1 ALL 10/18-1/22
Woman Power Sexual Support 61096-0034-1 ALL 10/18-11/21
Woman Power Sexual Support 61096-1034-1 ALL 10/18-11/21
Diet Power Dieting 61096-0004-1 ALL 10/18-4/22
Brain Power Focus 61096-0033-1 ALL 10/18-1/22
MenoPower Menopause 61096-0014-1 ALL 10/18-1/22
MenoPower Menopause 61096-1014-1 ALL 10/18-1/22
Bone Builder Bone health 61096-0012-1 ALL 10/18-4/22
Bone Builder Bone Health 61096-1012-1 ALL 10/18-4/22
AllergEase Allergies 61096-0003-1 ALL 10/18-5/22
Cold + Flu Relief Colds 61096-0002-1 ALL 10/18-1/21
SleepEase Sleep Aid 61096-0001-1 ALL 10/18-11/21
SleepEase Sleep Aid 61096-1001-1 ALL 10/18-11/21
DigestivEase Stomach Aid 61096-0005-1 ALL 10/18-8/21
TravelEase Jet Lag 61096-0007-1 ALL 10/18-1/22
TravelEase Jet Lag 61096-1007-1 ALL 10/18-1/22
Party Relief Hangover 61096-0030-1 ALL 10/18-6/22
Party Relief Hangover 61096-1030-1 ALL 10/18-6/22
Arnica Power Bruising 61096-0032-1 ALL 10/18-7/22
Snore Soother Snoring 61096-0024-1 ALL 10/18-1/22
Stress Relief Stress Aid 61096-0006-1 ALL 10/18-4/22
Stress Relief Stress Aid 61096-1006-1 ALL 10/18-4/22
PMS Support PMS 61096-0031-1 ALL 10/18-7/21
Life Detoxer Lung Support 61096-0023-1 ALL 10/18-8/21
Life Detoxer Lung Support 61096-1023-1 ALL 10/18-8/21
ImmunoBooster Immune Aid 61096-0038-1 ALL 10/18-11/21
Body Skin Tonic Dry Skin 61096-0017-1 ALL 10/18-11/21
Acne Tonic Acne 61096-0027-1 ALL 10/18-11/21
Body Balance Adrenal 61096-0039-1 ALL 10/18-7/22

Eight and Company LLC, d/b/a Sprayology is notifying its retailers and direct consumers by letter and is arranging for return and replacement of the recalled products.

Consumers and retailers that have product which is being recalled should discontinue use/distribution and contact Eight and Company LLC, d/b/a Sprayology to make arrangements to return the product by calling 1-240-224-7866 Monday – Friday 9:00 am – 3:30 pm EST or by email at recall@sprayology.com.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

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


Company Contact Information

Consumers:
240-224-7866
recall@sprayology.com
Media:
Eleanor Whalen
240-224-7866
ewhalen@sprayology.com