Recall: Envoachem Pharmaceuticals Dyural-40 And Dyural-80 Convenience Kits Containing Sodium Chloride Injection, USP, 0.9%
On 2018-12-17, the FDA announced that Asclemed USA is conducting a recall on Dyural-40 And Dyural-80 Convenience Kits Containing Sodium Chloride Injection, USP, 0.9% due to a possible lack of proper labeling. The recalled products were sold under the brand name(s) Envoachem Pharmaceuticals during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 3 drugs recalls due to potential lack of proper labeling, including sodium chloride injection, usp, 0.9%, 10 ml fill in a 10 ml vial, robaxin (methocarbamol tablets, usp) 750mg tablets and more. Additionally, there have been 16 drug and medical device recalls due to other health hazards as well as 95 food recalls.
Company Contact Information:
Name: Asclemed USA
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Dyural-40 and Dyural-80 Convenience Kits Containing Sodium Chloride Injection, USP, 0.9%
Brand Name(s): Envoachem Pharmaceuticals
Reason for Recall: Lack of Proper Labeling
Official Recall Date: 2018-12-17
Additional information provided by the FDA.gov:
Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.