Recalls / Class II
Class IID-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.
- Brand name
- Fluconazole
- Generic name
- Fluconazole
- Active ingredient
- Fluconazole
- Route
- Intravenous
- NDCs
- 0338-6045, 0338-6046
- FDA application
- ANDA076766
- Affected lot / code info
- Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Why it was recalled
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 30,910 bags
- Distribution pattern
- United States, United Arab Emirates, and Colombia
Timeline
- Recall initiated
- 2016-12-06
- FDA classified
- 2016-12-19
- Posted by FDA
- 2016-12-28
- Terminated
- 2018-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0206-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.