Hospira Recalls Lactated Ringer's Injection Due to Confirmed Mold Particulates
Hospira Inc. is recalling 142,644 bags of Lactated Ringer's and 5% Dextrose Injection USP due to confirmed mold particulates in the solution.
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 source text explicitly states the agency classification is Class I, which mandates a score of 5 per the rubric.
Plain-English summary
Hospira Inc. is recalling 142,644 bags of Lactated Ringer's and 5% Dextrose Injection USP, 1000 mL, flexible containers. The product is identified by NDC 0409-7929-09, Lot # 35-118- JT, and an expiration date of 11/15. The recall is classified as Class I by the FDA.
The recall was initiated due to a confirmed customer complaint of particulate matter floating within the solution of the primary container. The particulates were consistent with mold. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected product immediately. The source text does not specify additional consumer actions or contact information for the recalling firm.
The recalled product
- Product
- LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluid
- Hazard
- Affected units
- 142,644
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 # 35-118- JT
- Exp. 11/15
Distribution
Distributed nationwide across the United States.
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