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Teva Recalls Lot of Amikacin Sulfate

March 11, 2016

Potential presence of particulate matter identified as glass in one vial

Teva Pharmaceuticals has voluntary recalled 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 number is: 4750915.
 
If present in an intravenous drug, glass particulate 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 also staphylococcal infections. Amikacin sulfate injection 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.
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