Baxter Recalls Fluconazole Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling 30,910 bags of Fluconazole Injection due to confirmed customer complaints of leaking bags, which compromises sterility.
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 FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a risk of harm (loss of sterility in an IV product) where injury has not yet been reported is scored as 4 (Severe) to ensure appropriate caution, as it exceeds the 'theoretical' threshold of a score 3.
Plain-English summary
Baxter Healthcare Corporation is recalling 30,910 bags of Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL). The product is a 100 mL single-dose Intravia container bag intended for intravenous use. The specific lot number is P344028, with an expiration date of 12/31/2017.
The recall was initiated due to a lack of assurance of sterility. This issue stems from confirmed customer complaints regarding leaking bags. The affected product was distributed in the United States, United Arab Emirates, and Colombia.
Healthcare providers and patients should stop using the affected product immediately. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- FLUCONAZOLE (FLUCONAZOLE)
- Brand
- FLUCONAZOLE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Antifungal Injection
- Affected units
- 30,910
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 (3)
- Lot #: P344028 on bags
- P344028A on shipping container
- Exp 12/31/2017
Distribution
Distribution scope not specified by the agency.
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