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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 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.
- Category
- Drug — Prescription Injectable
- 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.
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