Class II
Terminated
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
This recall has been terminated (originally issued June 1, 2016).
- Company
- Teva North America
- Recall Initiated
- April 27, 2016
- Posted
- June 1, 2016
- Recall Number
- D-0868-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 546 bags
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Due to potential for leaking bags.
Distribution
Nationwide
Lot / Code Info
Lot # 2520715, Exp Date: 7/17
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