Agency classClass IIOur severity:Severe FDA (Drugs)·D-0788-2017·Announced 2017-05-24

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: sterility
packaging-leak
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.

See all 2 products in this recall →

Same brand · FLUCONAZOLE

Moderate
Fluconazole Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2017-05-10
Moderate
Harvard Drug Group Recalls Fluconazole Tablets for Failed Dissolution
FDA (Drugs) · 2017-05-10
Moderate
Dr. Reddy's Recalls Flucanazole Tablets Due to Dissolution Failures
FDA (Drugs) · 2017-02-08
High
Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures
FDA (Drugs) · 2017-02-08
Moderate
Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures
FDA (Drugs) · 2017-02-08

Same manufacturer · Baxter Healthcare Corporation

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Baxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
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Same hazard · sterility