Teva issues US recall of amikacin sulfate injection due to glass identified in vials

pharmafile | March 10, 2016 | News story | Manufacturing and Production Teva, amikacin sulfate, glass, recall 

Teva Pharmaceuticals has announced a voluntary recall of one lot of amikacin sulfate injection USP vials due to the potential presence of particulate matter identified as glass in one vial.

Teva has, to date, not received any reports of adverse events or complaints related to this recall but has indicated that 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 seriously, there is also the risk of blockage and clotting in blood vessels, which may be life threatening if a critical organ is affected.

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. It is in a class of medications called aminoglycoside antibiotics and is packaged in pharmacy bulk packages.

Teva has issued an Urgent Drug Recall letter to its direct customers, which include wholesalers, retailers and pharmacies. The company is arranging for impacted product to be returned to Inmar.

Sean Murray

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