Drug product
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
D-0868-2016
Product summary
- Event
- Event 74180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 546 bags
- Official record key
drug-enforcement:D-0868-2016
Official wording
Reason: Lack of Assurance of Sterility: Due to potential for leaking bags.
Code information: Lot # 2520715, Exp Date: 7/17
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility