The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0286-2015·Announced 2014-12-03

Hospira Recalls 0.45% Sodium Chloride Injection Due to Sterility Concerns

Hospira is recalling 784,920 bags of 0.45% Sodium Chloride Injection because punctures in the packaging may compromise sterility and cause leaks.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an intravenous product.

Plain-English summary

Hospira, Inc. is recalling 784,920 bags of 0.45% Sodium Chloride Injection, USP, 1000 mL container. The product is prescription-only and was distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands. The recall involves specific lots with expiration dates ranging from September 2015 to January 2015.

The recall was initiated due to a lack of assurance of sterility. The FDA identified a potential for punctures through the overwrap and primary container, which may result in IV bag leaks. This defect could compromise the sterile integrity of the medication.

Healthcare providers and patients should stop using the affected product immediately. Consumers 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 returned to the supplier or disposed of according to local regulations.

The recalled product

Product
0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7985-09.
Manufacturer
Hospira Inc.
Category
Drug — IV Fluids
Hazard
Affected units
784,920

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 # 33-027-JT
  • Exp.09/15 Lot # 33-045-JT
  • Exp.09/15 Lot # 33-097-JT
  • Exp.09/15 Lot # 35-068-JT
  • Exp.11/15 Lot # 36-112-JT
  • Exp.12/15 Lot # 37-012-JT
  • Exp.01/15

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 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 11 products in this recall →

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