Hospira Recalls Lactated Ringer's Injection Due to Non-Sterility
Hospira is recalling Lactated Ringer's and 5% Dextrose Injection due to a confirmed report of non-sterility involving spore-like particulates consistent with mold.
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 recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Hospira, Inc. is recalling 136,224 flexible containers of Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL. The recall is being conducted because of a confirmed customer report that the product contained spore-like particulates consistent with mold, indicating a non-sterility issue.
The affected product is identified by NDC 0409-7929-09. The specific lot number is 12-160-JT*, with an expiration date of 12/01/13. The asterisk in the lot number may be followed by 01 or 90. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the manufacturer for further instructions. This recall is classified as Class I by the FDA.
The recalled product
- Product
- Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluids
- Hazard
- Affected units
- 136,224
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 # :12-160-JT*
- Exp 12/01/13
- lot number * may be followed by 01 or 90
Distribution
Distributed nationwide across the United States.
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