Recall: AuroMedics Ampicillin And Sulbactam For Injection USP, 3 Grams/ Single-Dose Vial
On 2018-05-07, the FDA announced that AuroMedics Pharma is conducting a recall on Ampicillin And Sulbactam For Injection USP, 3 Grams/ Single-Dose Vial 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 1 drugs recalls due to potential particulate matter, including amiodarone hcl, vancomycin hydrochloride for injection and more. Additionally, there have been 27 drug and medical device recalls due to other health hazards as well as 94 food recalls.
Company Contact Information:
Name: AuroMedics Pharma
Phone: (888) 238-7880
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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: Ampicillin and Sulbactam for Injection USP, 3 grams/ Single-Dose vial
Brand Name(s): AuroMedics
Reason for Recall: Presence of visible particulate matter
Official Recall Date: 2018-05-07
Additional information provided by the FDA.gov:
AuroMedics Pharma LLC is voluntarily recalling two lots of Ampicillin and Sulbactam for Injection USP, 3 grams*/ Single-Dose vial, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients. 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.