UPDATED: Presence of Glass Prompts Injection Recall from Teva Pharmaceuticals
Teva Pharmaceuticals has announced a voluntary recall of one lot of amikacin sulfate injection USP, 1 gram/4 mL (250 mg/mL) vials due to the potential presence of glass.
The affected product comes from lot number 4750915. This lot bears an expiration date of 09/01/2017 and a National Drug Code number of 0703-9040-01(individual pack) or 0703-9040-03(shelf pack).
Administering a glass particulate through injection can result in local irritation or swelling. 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, such as certain strains of Gram-negative bacteria or staphylococcal infections.
Teva is arranging for impacted product to be returned. Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately.
Consumers with questions about this recall can contact Teva Pharmaceuticals at (888) 838-2872, option 3, then option 4.
Update: Teva has expanded its recall to include additional lots of amikacin sulfate injection USP. For details of the recalled products, see the Food and Drug Administration's release.