Product: Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
Reason for recall: CGMP Deviations
Recall initiated: 20160729
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated