The Recall Desk
CriticalFDA (Drugs)·D-263-2013·Announced 2013-04-24

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.

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 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.

Related recalls

Same manufacturer · Hospira Inc.

See all →

Same hazard · non sterility

See all →