Baxter Recalls Fluconazole Injection Bags Due to Seal Defects
Baxter Healthcare is recalling 31,130 bags of Fluconazole Injection due to potential leaks from incomplete seals, which may compromise 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential sterility issue due to packaging defects without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Baxter Healthcare Corporation is recalling 31,130 bags of Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL). The product is packaged in 100 mL Single-Dose INTRAVIA Container bags, with 10 bags per carton. The specific lot affected is P318394, with an expiration date of 05/31/16. The product is identified by NDC 0338-6046-48 and Product Code 2J1446.
The recall was initiated due to complaints of leaks caused by an incomplete seal at the bag seam. This defect creates a lack of assurance of sterility for the intravenous medication. The affected product was distributed nationwide in the United States, as well as in the United Arab Emirates and Colombia.
Healthcare providers and patients should stop using the affected lot of Fluconazole Injection. Consumers should check their medication for the specific lot number P318394 and expiration date 05/31/16. If the product matches these details, it should be returned to the pharmacy or healthcare provider for replacement or refund.
The recalled product
- Product
- FLUCONAZOLE (FLUCONAZOLE)
- Brand
- FLUCONAZOLE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Antifungal Injection
- Affected units
- 31,130
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 (2)
- Lot #: P318394
- Exp 05/31/16
Distribution
Distributed nationwide across the United States.
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