Recalls / Class II
Class IID-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.
- Brand name
- Fluconazole
- Generic name
- Fluconazole
- Active ingredient
- Fluconazole
- Route
- Intravenous
- NDCs
- 0338-6045, 0338-6046
- FDA application
- ANDA076766
- Affected lot / code info
- Lot #: P318394; Exp 05/31/16
Why it was recalled
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 31,130 bags
- Distribution pattern
- Nationwide, United Arab Emirates, and Columbia
Timeline
- Recall initiated
- 2014-12-23
- FDA classified
- 2015-01-26
- Posted by FDA
- 2015-02-04
- Terminated
- 2016-04-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0380-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.