FDA-Drug2016-10-19Class II
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).
Teva Pharmaceuticals USA
Hazard
CGMP Deviations
Sold states
Nationwide and Puerto Rico
Affected count
11,844 vials
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0024-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief