Baxter Recalls Fluconazole Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling Fluconazole Injection bags because customer complaints indicated leaks that compromise sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of infection or serious injury, aligning with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
Baxter Healthcare Corporation is recalling Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bags. The recall involves 113,590 bags distributed in the United States, United Arab Emirates, Colombia, and Canada. The specific lots affected are P344028/P344028A (Exp 12/31/17), P352377 (Exp 8/31/18), and P348136 (Exp 4/30/18).
The recall was initiated due to a lack of assurance of sterility. Customer complaints were received regarding the presence of leaks in the product packaging. Leaks in single-dose intravenous containers can compromise the sterile environment required for the medication.
Healthcare providers and patients should stop using the affected lots and contact Baxter Healthcare Corporation for further instructions or replacement products. The FDA has classified this as a Class II recall.
The recalled product
- Product
- FLUCONAZOLE (FLUCONAZOLE)
- Brand
- FLUCONAZOLE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Antifungal Injection
- Hazard
- Affected units
- 113,590
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: P344028/P344028A
- Exp 12/31/17
- P352377
- Exp 8/31/18
- P348136
- Exp 4/30/18
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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