Baxter Recalls Metronidazole Injection Due to Sterility Assurance Concerns
Baxter Healthcare Corp. is recalling specific lots of Metronidazole Injection USP due to a manufacturing defect that may compromise sterility.
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. Per the rubric, FDA Class II recalls involving potential sterility issues in intravenous products are classified as Severe (Score 4) due to the risk of significant injury or infection, even if specific hospitalization reports are not yet detailed in the text.
Plain-English summary
Baxter Healthcare Corp. is recalling 172,296 units of Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container (NDC 0338-1055-48). The recall affects specific lot numbers P280123 and P280123A with an expiration date of 2/14. The product was distributed nationwide and in Puerto Rico.
The recall was initiated due to a lack of assurance of sterility. A manufacturing issue occurred during the sealing of the closure assembly at the administration port, creating a potential for leakage. This defect may compromise the sterility of the intravenous medication.
Healthcare providers and patients should stop using the affected lots immediately. The FDA classifies this as a Class II recall, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- METRONIDAZOLE (METRONIDAZOLE)
- Brand
- METRONIDAZOLE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Antibiotic
- Affected units
- 172,296
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 #: P280123
- P280123A
- Exp 2/14
Distribution
Part of a larger recall action
This product is one of 6 recalled by Baxter Healthcare Corp. 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 6 products in this recall →Related recalls
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