Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination
- Company Announcement Date:
- October 09, 2018
- FDA Publish Date:
- October 10, 2018
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionPossible microbial contamination
- Company Name:
- Eight and Company LLC, dba Sprayology
- Brand Name:
- Product Description:
Product DescriptionHomeopathic Aqueous-Based Medicines
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.
|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|
|Bone Builder Bone health||61096-0012-1||ALL||10/18-4/22|
|Bone Builder Bone Health||61096-1012-1||ALL||10/18-4/22|
|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 email@example.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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.