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| The United States: BioLyte Laboratories issues voluntary nationwide recall due to the voluntary nationwide recall initiated by King Bio Inc. (a raw material supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel due to possible microbial contamination (English Only) |
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The US Food and Drug Administration (FDA) announces that BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or injury due to the use of this product.
The 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm620481.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 21 Jul 2018, 23 Aug 2018, 29 Aug 2018, 30 Aug 2018 and 7 Sep 2018.
Ends/Friday, Sep 14, 2018
Issued at HKT 16:00
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