FDA-Drug2021-08-25Class II
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
Teva Pharmaceuticals USA
Hazard
Lack of Assurance of Sterility
Sold states
Product was distributed Nationwide, including Puerto Rico.
Affected count
4,712 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0733-2021Don't want to check this manually?
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