Linezolid various strengths in dextrose

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Walgreens Infusion Services

Origin

TX, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0359-2015

Other Linezolid recalls

See all

Class II · Moderate risk Terminated Mar 27, 2018

Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma…

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-242-51 D-0703-2018

Class I · High risk Terminated Dec 20, 2017

Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate…

Reason Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

AuroMedics Pharma LLC NDC 55150-242-51 D-0337-2018

Class II · Moderate risk Terminated Jun 17, 2016

Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454…

Reason CGMP Deviations

Teva North America NDC 0703-9060-31 D-1495-2016

Class II · Moderate risk Terminated Apr 27, 2016

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container…

Reason Lack of Assurance of Sterility: Due to potential for leaking bags.

Teva North America NDC 0703-9060-31 D-0868-2016

Class II · Moderate risk Terminated Nov 14, 2014

Linezolid active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…

Attix Pharmaceuticals D-764-2015