Hospira Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
Hospira Inc. is recalling 0.9% Sodium Chloride Injection, USP, 1000 mL containers due to the presence of small grey/brown brass particulates.
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 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 I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Hospira Inc. is recalling 691,356 containers of 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only. The product is identified by NDC 0409-7983-09 and Lot # 25-037-JT*, with an expiration date of 1JAN2015. The lot number may be followed by 01 or 90.
The recall was initiated due to reports of small grey/brown particles found in the primary container, which were identified as brass particulates. The product was distributed nationwide.
Healthcare providers and consumers should stop using the affected product and contact Hospira Inc. for further instructions or replacement.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluids
- Affected units
- 691,356
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 #: 25-037-JT*
- Exp 1JAN2015
- Note: the lot number may be followed by 01 or 90
Distribution
Distributed nationwide across the United States.
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