Drug & medication recalls Moderate risk

Amneal Pharmaceuticals recalls Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ…

Recall date
December 15, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0610-2018
FDA classification
Class II
Brand / firm
Amneal Pharmaceuticals
Sold / distributed
U.S.A Nationwide

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, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

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