Teva Pharmaceuticals based in North Wales, Pennsylvania, announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL and 1 tram/4mL vials as a result of the potential presence of glass particulate matter.
Amikacin Sulfate Injection is used in the short-term treatment of serious infection due to strains of Gram-negative bacteria, and has been shown to be effective in treating staphylococcal infections.
If glass particulate is administered in an intravenous drug, it may result in local irritation or swelling as a reaction to the foreign material. More serious potential outcomes would be blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected, according to the U.S. Food and Drug Administration (FDA).
Amikacin Sulfate Injection is in a class of medications called aminoglycoside antibiotics and is packaged in pharmacy bulk packages and distributed nationwide through wholesalers, retailers and pharmacies.
Medscape Medical News reported that they do not provide specifics related to drug supply but that there is no shortage of the drug. The recalled lot has an expiration date of September 2017.
To date, Teva has not received any reports of adverse events or complaints connected to this recall. The company is arranging for the impacted product to be returned to Inmar. Consumers with an existing inventory of the recalled product should stop use immediately. Teva has sent an Urgent Drug Recall letter to its direct customers.