Recall: AuroMedics Levofloxacin In 5% Dextrose Injection 250mg/50mL
On 2018-01-17, the FDA announced that AuroMedics Pharma is conducting a recall on Levofloxacin In 5% Dextrose Injection 250mg/50mL due to a possible particulate matter. The recalled products were sold under the brand name(s) AuroMedics during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 6 drugs recalls due to potential unintended use, including nexterone 150mg/100ml injection, clopidogrel tablets usp, 75 mg and more. Additionally, there have been 10 drug and medical device recalls due to other health hazards as well as 114 food recalls.
Company Contact Information:
Name: AuroMedics Pharma
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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: Levofloxacin in 5% Dextrose Injection 250mg/50mL
Brand Name(s): AuroMedics
Reason for Recall: Particulate Matter
Official Recall Date: 2018-01-17
Additional information provided by the FDA.gov:
AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter.
Risk Statement: Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall. 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.