Drug recall D-0380-2015
Product
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.
Lots and codes
Lot #: P318394; Exp 05/31/16
Recall details
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL
- Quantity
- 31,130 bags
- Distribution
- Nationwide, United Arab Emirates, and Columbia
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 23, 2014
- Terminated
- April 21, 2016
Related products
- Fluconazole – drug information
- NDC 0338-6046 Fluconazole · Fluconazole 200 mg/100mL · Baxter Healthcare Company
- NDC 0338-6045 Fluconazole · Fluconazole 400 mg/200mL · Baxter Healthcare Company