Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, I
Recalled October 19, 2016 · FDA recall D-0024-2017 · Teva Pharmaceuticals USA
Hazard
CGMP Deviations · FDA Class II
Units
11,844 vials
Sold at
Nationwide and Puerto Rico
Description
CGMP Deviations
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).
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →