The National Agency for Food and Drug Administration and Control has been informed that Eight and Company LLC, d/b/a Sprayology USA is voluntarily recalling all lots within expiry from 10/18 to 7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, USA have been recalled due to possible microbial contamination.
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 Sprayolog has not to date received any reports of adverse events related to this recall.
The products are for assorted symptom relief and 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 in USA via wholesale, retail and online sales.
Affected Products Information.
Manufacturer: King Bio, Inc. facility in Asheville, NC. Product was distributed in USA.
| 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 |
NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution, and use of the recalled products.
Healthcare providers and anyone in possession of these recalled products should submit them to the nearest NAFDAC office.
Patients and healthcare providers are advised to report adverse events related to the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
NAFDAC………………Safeguarding the health of the Nation!!!
