The Recall Desk
HighFDA (Drugs)·D-0285-2015·Announced 2014-12-03

Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

Hospira is recalling 16.5 million bags of 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

What this means for you

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 is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility/leaks) for a medical product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Hospira Inc. is recalling 16,487,040 bags of 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only. The product is manufactured by Hospira, Inc., in Lake Forest, IL, and carries the NDC 0409-7983-09.

The recall was initiated due to a lack of assurance of sterility. The source text indicates a potential for punctures through the overwrap and primary container, which may result in IV bag leaks. The affected lots have expiration dates ranging from 08/15 to 01/16.

The product was distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands. Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice and stop using the product if it matches the affected lots.

The recalled product

Product
0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Manufacturer
Hospira Inc.
Category
Drug — IV Fluids
Hazard
Affected units
16,487,040

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 (20)

  • Lot # 32-044-JT
  • Exp. 08/15 Lot # 32-072-JT
  • Exp. 08/15 Lot # 32-102-JT
  • Exp. 08/15 Lot # 33-028-JT
  • Exp. 09/15 Lot # 33-046-JT
  • Exp. 09/15 Lot # 33-049-JT
  • Exp. 09/15 Lot # 33-061-JT
  • Exp. 09/15 Lot # 33-085-JT
  • Exp. 09/15 Lot # 33-096-JT
  • Exp. 09/15 Lot # 33-101-JT
  • Exp. 09/15 Lot # 33-102-JT
  • Exp. 09/15 Lot # 34-016-JT
  • Exp. 10/15 Lot # 34-085-JT
  • Exp. 10/15 Lot # 34-122-JT
  • Exp. 10/15 Lot # 34-123-JT
  • Exp. 10/15 Lot # 35-026-JT
  • Exp. 11/15 Lot # 35-030-JT
  • Exp. 11/15 Lot # 35-067-JT
  • Exp. 11/15 Lot # 36-002-JT
  • Exp. 12/15 Lot # 36-029-JT

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 →

Related recalls

Same manufacturer · Hospira Inc.

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Same hazard · sterility

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