Why it was recalled
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: P318394; Exp 05/31/16
Where it was sold
Nationwide, United Arab Emirates, and Columbia
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0380-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 23, 2014
- FDA report date
- Feb 4, 2015
- Quantity
- 31,130 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0380-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70057
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P318394; Exp 05/31/16
- Postal code
- 60015-4625
- Report date
- Feb 4, 2015
- Product type
- Drugs
- Recall number
- D-0380-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 31,130 bags
- Termination date
- Apr 21, 2016
- Reason for recall
- Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide, United Arab Emirates, and Columbia
- Recall initiation date
- Dec 23, 2014
- Initial firm notification
- Letter
- Center classification date
- Jan 26, 2015