The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-262-2013·Announced 2013-04-24

Hospira Recalls Lactated Ringer's Injection Due to Mold Contamination

Hospira is recalling 143,136 units of Lactated Ringer's and 5% Dextrose Injection due to confirmed mold contamination.

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 agency classification is FDA Class I, which mandates a minimum severity score of 5 according to the rubric.

Plain-English summary

Hospira Inc. is recalling 143,136 flexible containers of Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL. The recall is due to a confirmed customer complaint that the product was contaminated with mold.

The affected product is identified by NDC 0409-7929-09. The specific lot number is 05-019-JT*, with an expiration date of 05/01/13. The asterisk in the lot number may be followed by 01, 90, or 91. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact their supplier or Hospira for instructions on return or disposal.

The recalled product

Product
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.
Manufacturer
Hospira Inc.
Affected units
143,136

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 (5)

  • Lot #: 05-019-JT*
  • Exp 05/01/13
  • lot number * may be followed by 01
  • 90
  • or 91.

Distribution

Distributed nationwide across the United States.

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