FDA recall D-0023-2017

Product

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).

Reason for recall

CGMP Deviations

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-07-29

Report date

2016-10-19

Termination date

2018-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0023-2017