FDAFDA · Food and drugs·Recall number D-0023-2017
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
Published October 19, 2016 · Recall initiated: July 29, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot # 7080315, 7400315, 7410315, 7980415
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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