RecallDepth
Class II Terminated

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).

Company
Teva Pharmaceuticals Usa
Recall Initiated
July 29, 2016
Posted
October 19, 2016
Recall Number
D-0023-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
27,547 vials
Firm Location
North Wales, PA, United States

Reason for Recall

CGMP Deviations

Distribution

Nationwide and Puerto Rico

Lot / Code Info

Lot # 7080315, 7400315, 7410315, 7980415

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