药 物 回 收
|
| |
| The United States: Sprayology issues voluntary nationwide recall of homeopathic aqueous-based medicines due to microbial contamination (English Only) |
| |
The US Food and Drug Administration (FDA) announces that 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. For details of the affected products, please refer to the website in FDA.
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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm622919.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news on products by King Bio Inc. was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 21 Jul 2018, with the latest update posted on 5 Oct 2018.
Ends/Thursday, Oct 11, 2018
Issued at HKT 15:00
|
| |
|
