Hospira Recalls Ondansetron Injection Due to Particulate Matter
Hospira is recalling 340,600 vials of Ondansetron Injection due to the discovery of particulate matter in a preceding lot.
What this means for you
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 is described as a precautionary measure due to particulate matter in a preceding lot, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Hospira, Inc. is recalling 340,600 vials of Ondansetron Injection, USP, 4mg/2mL (2mg/ml), 2mL single-dose Fliptop Vials. The affected product is identified by Lot 25394DK, with an expiration date of 01/2015, and NDC 0409-4755-03. The product is distributed nationwide.
The recall was initiated as a precautionary measure following the discovery of two particles in a lot that preceded the recalled lot. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected lot and contact Hospira, Inc. for further instructions or replacement. Consumers should check their medication for the specific lot number and expiration date listed above.
The recalled product
- Product
- ONDANSETRON (ONDANSETRON)
- Brand
- ONDANSETRON
- Manufacturer
- Hospira, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 340,600
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 25394DK
- exp. 01/2015
Distribution
Distributed nationwide across the United States.
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