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.
Reported: February 4, 2015 Initiated: December 23, 2014 #D-0380-2015
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.
Reason for Recall
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 31,130 bags
- Distribution
- Nationwide, United Arab Emirates, and Columbia
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corp.. Units affected: 31,130 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 4, 2015. Severity: Moderate. Recall number: D-0380-2015.
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