The Recall Desk
SevereFDA (Drugs)·D-613-2013·Announced 2013-07-03

Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

Hospira is voluntarily recalling 0.45% Sodium Chloride Injection 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the loss of sterility in an intravenous product is a significant hazard.

Plain-English summary

Hospira, Inc. is voluntarily recalling 136,584 units of 0.45% Sodium Chloride Injection, USP, 250 mL. The recall is due to possible leaking bags, which raises a lack of assurance of sterility for the product.

The affected product is identified by Lot # 93-153-JT with an expiration date of 9/12. The distribution pattern includes nationwide distribution, Puerto Rico, U.S. Virgin Island, Libya, and Saudi Arabia.

Consumers and healthcare providers should stop using the affected product and contact Hospira, Inc. for further instructions or a replacement.

The recalled product

Product
SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand
SODIUM CHLORIDE
Manufacturer
Hospira Inc.
Affected units
136,584

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 (2)

  • Lot #: 93-153-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 →