FDA Recall Metronidazole
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Metronidazole with NDC 0338-1055 was initiated on 01-21-2016 as a Class I recall due to presence of particulate matter: identified as a cloth fiber. The latest recall number for this product is D-0863-2016 and the recall is currently terminated as of 02-26-2018 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0863-2016 | 01-21-2016 | 06-01-2016 | Class I | 334,560 bags | 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. | Terminated |
| D-629-2013 | 05-21-2013 | 07-10-2013 | Class II | 172,296 units | Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.