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.
FDA recall notice · announced December 28, 2016 · Baxter Healthcare
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: United States, United Arab Emirates, and Colombia
Lot/code information: Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Quantity: 30,910 bags
Status: Terminated
Products in this recall event:
- 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. (D-0206-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.