Linezolid Injection — Class II drug recall D-0868-2016
Terminated recall by Teva North America, reported 2016-06-01, distributed nationwide. Lack of Assurance of Sterility: Due to potential for leaking bags.
| Recall number | D-0868-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva North America, Horsham, PA, United States |
| Recall initiated | 2016-04-27 |
| Classified | 2016-05-24 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2018-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 546 bags |
| Reason classes | sterility, packaging |
| NDC | 00703-9060-31, 00703-9060-33 |
| Lot numbers | 2520715, 7/17 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0868-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.