RecallDepth
Class II Terminated

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

Company
Amneal Pharmaceuticals Llc
Recall Initiated
August 31, 2017
Posted
November 22, 2017
Recall Number
D-0076-2018
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
14,000 vials
Firm Location
Glasgow, KY, United States

Reason for Recall

Presence of Particulate Matter

Distribution

MS, NC, OH, TX, UT

Lot / Code Info

Lot # AP160016; Exp. 05/18

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