Class II
Terminated
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.
This recall has been terminated (originally issued February 4, 2015).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- December 23, 2014
- Posted
- February 4, 2015
- Recall Number
- D-0380-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 31,130 bags
- Firm Location
- Deerfield, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Distribution
Nationwide, United Arab Emirates, and Columbia
Lot / Code Info
Lot #: P318394; Exp 05/31/16
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