Medicine recalls
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| The United States: Hellolife, Inc. issues voluntary worldwide recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to possible microbial contamination |
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The US Food and Drug Administration (FDA) announces that HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot packaged into 2-ounce amber bottles that were manufactured at the King Bio, Inc facility in Asheville, NC. The affected products are:
- Neuroveen (Lot: NV/030717D; Exp. Date: 07/19)
- Respitrol (Lot: RE/030717E; Exp. Date: 07/19)
- Thyroveev (Lot: TVV/030717F; Exp. Date: 07/19
- Compulsin (Lot: CO/030717B; Exp. Date: 07/19)
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. To date, HelloLife, Inc. has not received any reports of adverse events related to the recalled products.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm618926.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 21 Jul 2018, 23 Aug 2018 and 29 Aug 2018.
Ends/Thursday, Aug 30, 2018
Issued at HKT 15:00
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