The Recall Desk
SevereFDA (Drugs)·D-0969-2015·Announced 2015-04-29

Hospira Recalls 0.9% Sodium Chloride Injection Due to Human Hair Particulate

Hospira is recalling 0.9% Sodium Chloride Injection, USP, 250 mL, because a human hair was found sealed in the bag at the additive port area.

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 661,128 containers of 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only (NDC 0409-7983-02). The affected product is identified by Lot # 44-002-JT (the lot number may be followed by 01 to 99) and has an expiration date of 08/01/2016.

The recall was initiated because Hospira identified particulate matter in the product, which was determined to be a human hair sealed in the bag at the additive port area. The product was distributed nationwide.

Healthcare providers and patients should discontinue use of the affected lots and contact Hospira for further instructions or replacement.

The recalled product

Product
0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
Manufacturer
Hospira Inc.
Affected units
661,128

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 #: 44-002-JT (the lot number may be followed by 01 to 99)
  • Exp 08/01/2016

Distribution

Distributed nationwide across the United States.