The Recall Desk
SevereFDA (Drugs)·D-836-2013·Announced 2013-08-14

Hospira Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

Hospira Inc. is recalling 0.9% Sodium Chloride Injection, USP, 1000 mL containers due to the presence of small grey/brown brass particulates.

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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Hospira Inc. is recalling 691,356 containers of 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only. The product is identified by NDC 0409-7983-09 and Lot # 25-037-JT*, with an expiration date of 1JAN2015. The lot number may be followed by 01 or 90.

The recall was initiated due to reports of small grey/brown particles found in the primary container, which were identified as brass particulates. The product was distributed nationwide.

Healthcare providers and consumers should stop using the affected product and contact Hospira Inc. for further instructions or replacement.

The recalled product

Product
0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
Manufacturer
Hospira Inc.
Affected units
691,356

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 (3)

  • Lot #: 25-037-JT*
  • Exp 1JAN2015
  • Note: the lot number may be followed by 01 or 90

Distribution

Distributed nationwide across the United States.