Hospira Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
Hospira is recalling 264,432 bags of 0.9% Sodium Chloride Injection because the product may contain fibrous material.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Hospira Inc. is recalling 264,432 bags of 0.9% Sodium Chloride Injection, USP, 100 mL flexible container. The product is identified by NDC 0409-7984-23, Lot Number 05-201-JT, and an expiration date of 1MAY2013. The recall is due to the presence of particulate matter, as the product may contain fibrous material.
The affected product was distributed nationwide. This is a prescription-only medication. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.
Healthcare providers and patients should stop using the affected product and contact their pharmacist or Hospira for further instructions on returns or replacements.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluids
- Affected units
- 264,432
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 Number 05-201-JT
- Expiration Date 1MAY2013
Distribution
Distributed nationwide across the United States.
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