The Recall Desk
SevereFDA (Drugs)·D-0324-2015·Announced 2014-12-31

Hospira Recalls Heparin Sodium Injection Due to Human Hair Particulate

Hospira is recalling 63,378 units of Heparin Sodium injection because human hair was found sealed inside the container's administration port.

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 63,378 flexible container units of Heparin Sodium, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection. The recall affects Lot # 41-046-JT, which has an expiration date of 11/01/2015. The product is distributed nationwide and is available by prescription only.

The recall was initiated due to the presence of particulate matter. Specifically, a particulate confirmed as human hair was found sealed between the tube and film at the round seal of the unused administration port of the container.

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

The recalled product

Product
HEPARIN SODIUM (HEPARIN SODIUM)
Brand
HEPARIN SODIUM
Manufacturer
Hospira Inc.
Affected units
63,378

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 #: 41-046-JT
  • Exp 11/01/2015

Distribution

Distributed nationwide across the United States.