Teva Pharmaceuticals is recalling seven lots of Amikacin Sulface Injection, a treatment for serious infections, because there may be glass particles floating in the vials. Administration of glass particulate in an intravenous drug may cause local irritation or swelling in response to the foreign matter and could lead to more serious problems including blockage and clotting in the blood vessels, which may be life threatening if a critical organ is affected.
The recall involves specific lots of Amikacin Sulfate injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials. For a full list of lots and NDC#s, refer to the company’s press release.
Amikacin Sulfate injection 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 inections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease.
The injections belongs to a class of medications called amino glycoside antibiotics and is supplied as 2 mL and 4 mL vials packaged in shelf pack of 10 500-mg/3 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.
Teva has issued an Urgent Drug Recall Letter to its customers informing them of the recall nd to stop using the drug immediately.
In March, Teva announced a recall of one lot of Amikacin Sulfate injection due to the possibility of glass particulate in the vials. Customers with affected products were also notified and instructed to stop using the drug immediately.
Any adverse events or side effects related to this recall should be reported to the Food and Drug Administration (FDA) Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.