The Recall Desk
SevereFDA (Drugs)·D-611-2013·Announced 2013-07-03

Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

Hospira is voluntarily recalling 0.9% Sodium Chloride Injection in flexible containers due to possible leaking bags that may compromise sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable product, which poses a risk of serious injury or death if contaminated.

Plain-English summary

Hospira, Inc. is voluntarily recalling 0.9% Sodium Chloride Injection, USP, in polyolefin flexible containers. The recall covers specific 150 mL, 250 mL, 500 mL, and 1000 mL units manufactured by Hospira in Lake Forest, Illinois.

The recall was initiated due to a lack of assurance of sterility. The company identified possible leaking bags, which could potentially compromise the sterile integrity of the product. The affected units were distributed nationwide, as well as in Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia.

Healthcare providers and facilities should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. Patients should contact their healthcare provider if they have questions regarding the use of this product.

The recalled product

Product
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
Manufacturer
Hospira Inc.
Category
Drug — Injectable Solution
Hazard
Affected units
2,137,660

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 (14)

  • Lot #: a) 89-135-JT
  • 04-224-JT
  • 07-138-JT
  • Exp 4/13
  • 08-160-JT Exp. 8/13
  • b) 08-163-JT
  • 90-036-JT
  • 02-048-JT
  • Exp 2/13
  • c) 93-102-JT
  • 11-063-JT
  • Exp 9/12
  • d) 93-096-JT
  • Exp 11/12

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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Same hazard · sterility

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