Agency classClass IIOur severity:Severe FDA (Drugs)·D-0480-2017·Announced 2017-03-01

Hospira Recalls Metronidazole Injection Bags Due to Leaking

Hospira is recalling 578,784 bags of Metronidazole Injection due to a customer report of a leaking bag, which compromises 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as loss of sterility assurance) are categorized as Severe (Score 4), particularly when structural defects like leaking bags are involved.

Plain-English summary

Hospira Inc., a Pfizer company, is recalling 578,784 bags of METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container. The product is identified by NDC 0409-7811-24 and Lot 54-054-JT, with a date of 6/1/2017. The recall was initiated due to a customer report of a leaking bag, which raises concerns regarding a lack of sterility assurance.

The affected product was distributed nationwide and in Puerto Rico. This is a prescription-only medication intended for intravenous use. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should stop using the affected lots of Metronidazole Injection and contact their supplier or Hospira for further instructions. Consumers should not use the product if they have received it and should consult their healthcare provider for alternatives.

The recalled product

Product: METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
Manufacturer: Hospira Inc., A Pfizer Company
Category: Drug — Injection
Hazard: lack-of-sterility
leaking-container
Affected units: 578,784

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: 54-054-JT
6/1/2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Hospira Inc., A Pfizer Company

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Same hazard · lack of sterility