Metronidazole Injection USP — Class I drug recall D-0863-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-06-01, distributed nationwide. Presence of Particulate Matter: identified as a cloth fiber.
| Recall number | D-0863-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-01-21 |
| Classified | 2016-05-23 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2018-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 334,560 bags |
| Reason classes | specification failure |
| NDC | 00338-1055, 00338-1055-48 |
| Lot numbers | P339135 |
| Expiration dates | 2017-08-31 |
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 for recall
Presence of Particulate Matter: identified as a cloth fiber.
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-0863-2016. 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.