The Recall Desk
CriticalFDA (Drugs)·D-0392-2015·Announced 2015-02-25

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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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