The Recall Desk
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.

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 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.