FDA Drug recall 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…
- FDA Drug
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of 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… by Teva North America, citing lack of Assurance of Sterility: Due to potential for leaking bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0868-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-27 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva North America |
| Distribution | US |
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
Lack of Assurance of Sterility: Due to potential for leaking bags.
Identifiers
| code_info | Lot # 2520715, Exp Date: 7/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0868-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.