Recall: Fresenius Kabi Sodium Chloride Injection, USP, 0.9%, 10 ML Fill In A 10 ML Vial
On 2018-11-20, the FDA announced that Fresenius Kabi is conducting a recall on Sodium Chloride Injection, USP, 0.9%, 10 ML Fill In A 10 ML Vial due to a possible lack of proper labeling. The recalled products were sold under the brand name(s) Fresenius Kabi during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 4 drugs recalls due to potential lack of proper labeling, including robaxin (methocarbamol tablets, usp) 750mg tablets, montelukast sodium tablets, usp 10mg and more. Additionally, there have been 20 drug and medical device recalls due to other health hazards as well as 89 food recalls.
Company Contact Information:
Name: Fresenius Kabi
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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: Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial
Brand Name(s): Fresenius Kabi
Reason for Recall: Product Labeling Incorrectly
Official Recall Date: 2018-11-20
Additional information provided by the FDA.gov:
Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber 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.