Metronidazole Injection, Solution
FDA Recall NDC 0338-1055
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Metronidazole (NDC 0338-1055). A significant event, classified as Class I, was initiated on Jan 21, 2016 by Baxter Healthcare Corporation. The reported reason for this action was: "Presence of Particulate Matter: identified as a cloth fiber."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Presence of Particulate Matter: identified as a cloth fiber.
Jan 21, 2016
Jun 01, 2016
334,560 bags
Recall Profile & Regulatory Data
Event ID
73118
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 26, 2018
Product Description
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.
Batch or Lot Expiration Information
Lot# : P339135, Exp 08/31/2017
Affected Packages Involved in this Recall
0338-1055-48Product
Class II Terminated
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
May 21, 2013
Jul 10, 2013
172,296 units
Recall Profile & Regulatory Data
Event ID
65288
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide & Puerto Rico
Termination Date
Jun 18, 2015
Product Description
Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Batch or Lot Expiration Information
Lot# : P280123, P280123A, Exp 2/14
Affected Packages Involved in this Recall
0338-1055-48Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
