Home / Recalls / Teva North America / D-1495-2016

D-1495-2016 Class II Terminated

Recalled by Teva North America — Horsham, PA

Recall Details

Product Type: Drugs
Report Date: September 14, 2016
Initiation Date: June 17, 2016
Termination Date: February 7, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 92,480 containers

Product Description

Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)

Reason for Recall

CGMP Deviations

Distribution Pattern

Nationwide and Puerto Rico

Code Information

All Lots Within Expiry

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D-1494-2016 Class II — ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, (June 17, 2016)
D-1497-2016 Class II — Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungar (June 17, 2016)
D-1451-2016 Class III — mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple (May 31, 2016)
D-1449-2016 Class III — Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Ma (May 18, 2016)
D-0868-2016 Class II — Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), (April 27, 2016)