Fluconazole Injection recall: Sterility Concern
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.
Why was Fluconazole Injection recalled?
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: P318394; Exp 05/31/16
- 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.
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 31,130 bags
- Distribution
- Nationwide, United Arab Emirates, and Columbia
- Recall date
- February 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)