Amneal Pharmaceuticals LLC recalls Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amne…
- Recall date
- August 31, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0076-2018
- FDA classification
- Class II
- Brand / firm
- Amneal Pharmaceuticals LLC
- Sold / distributed
- MS, NC, OH, TX, UT
Why it was recalled
Presence of Particulate Matter
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Amneal Pharmaceuticals LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Amneal Pharmaceuticals LLC