AuroMedics Pharma is under your own accord recalling one large amount of Ampicillin and Sulbactam for Injection USP, 1.5 g in one-Dose vial (equal to 1 g ampicillin because the sodium salt plus .5 g Sulbactam because the sodium salt), towards the hospital level. Lot AFO l 17001-A, Expiry date 12 , 2018 has been discovered to contain glass particles.
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The affected Ampicillin and Sulbactam for Injection lot is packaged inside a carton that contains 10 vials, NDC: 55150-116-20. The merchandise could be recognized as a ‘clear vial stoppered with gray rubber stopper and sealed with aluminum seals getting a Royal Blue color polypropylene disc’. AuroMedics shipped the whole lot to wholesalers and/or hospitals nationwide on Feb 9, 2017.
The administration of the glass particulate, if there are any within an intravenous drug, may lead to local irritation or swelling as a result of the foreign material. More severe potential outcomes would come with blockage and clotting in bloodstream vessels, which can be existence-threatening.
The merchandise Ampicillin and Sulbactam for Injection can be used to treat infections because of susceptible strains of designated microorganism in skin and skin structure infections, intraabdominal infections and gynecological infections in grown-ups as well as for in management of skin and skin structure infection in pediatric patient twelve months and older.
AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and it is organizing for return/substitute etc. of remembered product. Consumers/distributors/ retailers which have the merchandise lot that is being remembered should immediately stop using and go back to host to purchase/contact their physician as appropriate.
Consumers with queries about this recall can contact AuroMedics Customer Service Monday through Friday from 9:00AM to five:00PM EST at 888-238-7880 Option 1. If you want assistance in coming back your products and have questions regarding the recall process, contact Inmar at 800-967-5952, Monday through Fridayfrom 8:30 AM to five:00 PM EST.