Drug recall D-0206-2017
Product
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.
Lots and codes
Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Recall details
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Quantity
- 30,910 bags
- Distribution
- United States, United Arab Emirates, and Colombia
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 6, 2016
- Terminated
- February 12, 2018
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