Teva Pharmaceuticals has announced a voluntary recall of one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of particulate matter identified as glass in one vial.
The recalled lot is 4750915 with exp. date 9/2017, 1 gram/4 mL, (250 mg/mL), NDC individual pack 0703-9040-01 NDC Shelf pack, 0703-9040-03
According to Teva’s press release from Friday, 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. To date, Teva has not received any reports of adverse events or complaints related to this recall.
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 is in a class of medications called aminoglycoside antibiotics and is packaged in pharmacy bulk packages, containing ten 1 gram/4 mL (250 mg/mL) vials per shelf pack. Amikacin sulfate injection 250 mg/mL, 4 mL vials were distributed nationwide through wholesalers, retailers and pharmacies.
Teva has issued an Urgent Drug Recall Letter to their direct customers. Teva is arranging for impacted product to be returned to Inmar. Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Customers should notify all retail and medical facility accounts. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities.