Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. Nor
Recalled August 25, 2021 · FDA recall D-0733-2021 · Teva Pharmaceuticals USA
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
4,712 vials
Sold at
Product was distributed Nationwide, including Puerto Rico.
Description
Lack of Assurance of Sterility
Product
Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →