D-0206-2017 Class II Terminated
FDA drug recall D-0206-2017 was initiated by Baxter Healthcare Corporation on Dec 6, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. The recall status is terminated (terminated Feb 12, 2018). Affected quantity: 30,910 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 28, 2016
- Initiation Date
- Dec 6, 2016
- Termination Date
- Feb 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,910 bags
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.
Reason for Recall
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Distribution Pattern
United States, United Arab Emirates, and Colombia
Code Information
Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0206-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026