Agency classClass IIOur severity:Severe FDA (Drugs)·D-629-2013·Announced 2013-07-10

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.

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. 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
Hazard: sterility
infection
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same brand · METRONIDAZOLE

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Baxter Recalls Metronidazole Injection Bags Due to Cloth Fiber Particulate Matter
FDA (Drugs) · 2016-06-01

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · sterility