Home / Recalls / Teva North America / D-0868-2016

D-0868-2016 Class II Terminated

Recalled by Teva North America — Horsham, PA

Recall Details

Product Type
Drugs
Report Date
June 1, 2016
Initiation Date
April 27, 2016
Termination Date
February 5, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
546 bags

Product Description

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot # 2520715, Exp Date: 7/17

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  • D-1453-2016 Class III — Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per (July 15, 2016)
  • D-1470-2016 Class II — Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufa (June 24, 2016)
  • D-1455-2016 Class II — Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Can (June 22, 2016)
  • 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-1495-2016 Class II — Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHAR (June 17, 2016)
  • D-1496-2016 Class II — Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenou (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)