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 Godoll

FDA recall notice · announced June 1, 2016 · Teva

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot # 2520715, Exp Date: 7/17
Quantity: 546 bags
Status: Terminated
Products in this recall event:
- 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: (D-0868-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.