Teva has announced the voluntary recall of one lot of amikacin sulfate injection USP, 1g/4mL (250gm/mL) vials due to the potential presence of glass in one vial. The recalled product has lot #4750915, expiration date 9/2017.
Teva has issued an Urgent Drug Recall Letter to their direct customers, in which they advise anyone with an existing inventory of the recalled lot should immediately stop use and distribution, and quarantine the product. Additionally, customers should notify all their retail and medical facility accounts.
The consequences of glass being administered intravenously may result in serious potential outcomes, including blockage and clotting in blood vessels, which could be life-threatening depending on the organ affected. As of yet, Teva has not received any reports of adverse events related to the recall.
Amikacin sulfate injection USP is an aminoglycoside antibiotic, used in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. It is also effective in treating staphylococcal infections.
For more information call (888) 838-2872, to report an adverse event related to the product visit FDA.gov.