FDA Drug recall D-0863-2016
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421…
- FDA Drug
- Class I
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class I recall of Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421… by Baxter Healthcare, citing presence of Particulate Matter: identified as a cloth fiber.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0863-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-01-21 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Reason
Presence of Particulate Matter: identified as a cloth fiber.
Identifiers
| ndc | 0338-1055-48 |
|---|---|
| code_info | Lot #: P339135, Exp 08/31/2017 |
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-0863-2016%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.