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FDAAugust 31, 2017drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of Particulate Matter

What to do

FDA enforcement status: Terminated

Brands named

amneal pharmaceuticalsamneal

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear