FDAFDA · Food and drugs·Recall number D-0076-2018
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Published November 22, 2017 · Recall initiated: August 31, 2017
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
Presence of Particulate Matter
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amneal Pharmaceuticals LLC
- Distributor
- MS, NC, OH, TX, UT
- Lot
- Lot # AP160016; Exp. 05/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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