The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-619-2013·Announced 2013-07-03

Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

Hospira is voluntarily recalling specific lots of 0.9% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility issue) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Hospira, Inc. is voluntarily recalling 2,933,936 units of 0.9% Sodium Chloride Injection, USP. The affected products include 50 mL and 100 mL vials with specific NDC codes and lot numbers. The recall is being conducted due to a lack of assurance of sterility caused by possible leaking bags.

The recalled products were distributed nationwide, as well as in Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia. The source text does not report any illnesses or injuries associated with this recall.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or destroyed according to local regulations.

The recalled product

Product
0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL (0409-7984-37), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Manufacturer
Hospira Inc.
Category
Drug — Injection
Hazard
Affected units
2,933,936

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 (7)

  • Lot #: a) 11-085-JT
  • Exp 11/13
  • b) 06-111-JT
  • Exp 12/12
  • c) 93-030-JT
  • 14-044-JT
  • Exp 9/12

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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