CLASS II Drug recall · Reported 24 May 2017 · FDA Enforcement Report
Fluconazole Injection, USP, 200 mg recalled by Baxter Healthcare
Baxter Healthcare is recalling Fluconazole Injection, USP, 200 mg/ (2mg/mL) Single-Dose Intravia Container. The recall was initiated on 15 May 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0788-2017
- FDA event ID
- 77247
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Fluconazole
- Manufacturer
- Baxter Healthcare Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2017
- FDA classified
- 18 May 2017
- Reported
- 24 May 2017
- Type
- Voluntary: Firm initiated
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 15 May 2017 | Recall initiated by company | |
| 18 May 2017 | Classified by FDA | +3 days |
| 24 May 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility: customer complaints received for the presence of leaks.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US and foreign countries: United Arab Emirates, Colombia, and Canada
Questions about this recall
Why was it recalled?
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Which lots are affected?
Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18
Where was it sold?
US and foreign countries: United Arab Emirates, Colombia, and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77247This product is part of a recall event; the main page for the event is Milrinone Lactate in 5% Dextrose Injection recalled by Baxter Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Milrinone Lactate in 5% Dextrose Injection recalled by Baxter HealthcareMilrinone Lactate In Dextrose | Baxter Healthcare | Sterility | IL |
More recalls from Baxter Healthcare
All 564| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
Other Fluconazole recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Packaging Defects | Nationwide |
| Drug | CLASS II | Fluconazole USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |