FDAFDA · Food and drugs·Recall number D-0868-2016
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
Published June 1, 2016 · Recall initiated: April 27, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Due to potential for leaking bags.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva North America
- Distributor
- Nationwide
- Lot
- Lot # 2520715, Exp Date: 7/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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