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

Source: FDA Drug Recalls
Wed Oct 10, 2018 12:25PM

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 INDICATIONNDC#LOT#Expirations
Rejuvenation Plus Energy61096-0035-1ALL10/18-11/21
Man Power Sexual Support61096-0025-1ALL10/18-1/22
Man Power Sexual support61096-1025-1ALL10/18-1/22
Woman Power Sexual Support61096-0034-1ALL10/18-11/21
Woman Power Sexual Support61096-1034-1ALL10/18-11/21
Diet Power Dieting61096-0004-1ALL10/18-4/22
Brain Power Focus61096-0033-1ALL10/18-1/22
MenoPower Menopause61096-0014-1ALL10/18-1/22
MenoPower Menopause61096-1014-1ALL10/18-1/22
Bone Builder Bone health61096-0012-1ALL10/18-4/22
Bone Builder Bone Health61096-1012-1ALL10/18-4/22
AllergEase Allergies61096-0003-1ALL10/18-5/22
Cold + Flu Relief Colds61096-0002-1ALL10/18-1/21
SleepEase Sleep Aid61096-0001-1ALL10/18-11/21
SleepEase Sleep Aid61096-1001-1ALL10/18-11/21
DigestivEase Stomach Aid61096-0005-1ALL10/18-8/21
TravelEase Jet Lag61096-0007-1ALL10/18-1/22
TravelEase Jet Lag61096-1007-1ALL10/18-1/22
Party Relief Hangover61096-0030-1ALL10/18-6/22
Party Relief Hangover61096-1030-1ALL10/18-6/22
Arnica Power Bruising61096-0032-1ALL10/18-7/22
Snore Soother Snoring61096-0024-1ALL10/18-1/22
Stress Relief Stress Aid61096-0006-1ALL10/18-4/22
Stress Relief Stress Aid61096-1006-1ALL10/18-4/22
PMS Support PMS61096-0031-1ALL10/18-7/21
Life Detoxer Lung Support61096-0023-1ALL10/18-8/21
Life Detoxer Lung Support61096-1023-1ALL10/18-8/21
ImmunoBooster Immune Aid61096-0038-1ALL10/18-11/21
Body Skin Tonic Dry Skin61096-0017-1ALL10/18-11/21
Acne Tonic Acne61096-0027-1ALL10/18-11/21
Body Balance Adrenal61096-0039-1ALL10/18-7/22

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.

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