Teva Recalls Seven Lots of Antibiotic

Teva Pharmaceuticals has announced a voluntary recall of seven lots of amikacin sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter.

Amikacin sulfate injection USP is used in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria and has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease. Amikacin sulfate injection belongs to a class of medications called aminoglycoside antibiotics and is supplied as 2-mL and 4-mL vials packaged in shelf pack of 10 500-mg/2-mL (250 mg/mL) and 1 gram/4-mL (250 mg/mL) vials. Amikacin sulfate injection 250 mg/mL, 2-mL and 4- mL vials were distributed nationwide through wholesalers, retailers, and pharmacies.

To date, Teva has not received any reports of adverse events or complaints related to this recall. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected.

Source: Teva Pharmaceuticals and US Food and Drug Administration

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