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The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.
Teva Pharmaceuticals announced on March 9, 2016 that it is recalling one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL), lot number 4750915, because of glass particulate matter found in one vial. Vials of the drug were distributed nationwide through wholesalers, retailers, and pharmacies. As of March 9, the company has not received any adverse event reports.
According to the company, amikacin sulfate injection USP is used as a short-term treatment of Gram-negative bacteria infections and staphylococcal infections as well as an initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease. Amikacin sulfate injection is packaged in pharmacy bulk packages, containing ten 1 gram/4 mL (250 mg/mL) vials per shelf pack.
Teva is asking customers to stop use and quarantine the product. Adverse events may be reported to FDA's MedWatch Adverse Event Reporting program