Drug recall D-0788-2017
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: customer complaints received for the presence of leaks.
Lots and codes
Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18
Recall details
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Quantity
- 113,590 bags
- Distribution
- US and foreign countries: United Arab Emirates, Colombia, and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 15, 2017
- Terminated
- August 10, 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