Fluconazole Injection, Solution
FDA Recall NDC 0338-6046
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Fluconazole (NDC 0338-6046). A significant event, classified as Class II, was initiated on May 15, 2017 by Baxter Healthcare Company. The reported reason for this action was: "Lack of assurance of sterility: customer complaints received for the presence of leaks."
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 II Terminated
Lack of assurance of sterility: customer complaints received for the presence of leaks.
May 15, 2017
May 24, 2017
113,590 bags
Recall Profile & Regulatory Data
Event ID
77247
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US and foreign countries: United Arab Emirates, Colombia, and Canada
Termination Date
Aug 10, 2018
Product Description
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48
Batch or Lot Expiration Information
Lot# : P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18
Affected Packages Involved in this Recall
0338-6046-48Product
0338-6045-37Product
Class II Terminated
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Dec 06, 2016
Dec 28, 2016
30,910 bags
Recall Profile & Regulatory Data
Event ID
75831
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States, United Arab Emirates, and Colombia
Termination Date
Feb 12, 2018
Product Description
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.
Batch or Lot Expiration Information
Lot# : P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Affected Packages Involved in this Recall
0338-6046-48Product
0338-6045-37Product
Class II Terminated
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Dec 23, 2014
Feb 04, 2015
31,130 bags
Recall Profile & Regulatory Data
Event ID
70057
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, United Arab Emirates, and Columbia
Termination Date
Apr 21, 2016
Product Description
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.
Batch or Lot Expiration Information
Lot# : P318394; Exp 05/31/16
Affected Packages Involved in this Recall
0338-6046-48Product
0338-6045-37Product
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.
