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.
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 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
- 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
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