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.
Reported: December 28, 2016 Initiated: December 6, 2016 #D-0206-2017
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 30,910 bags
- Distribution
- United States, United Arab Emirates, and Colombia
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 30,910 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Moderate. Recall number: D-0206-2017.
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