Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns
Hospira is recalling 142,152 bags of Heparin Sodium in 5% Dextrose Injection due to a confirmed report of fluid leaking from the primary container, which compromises sterility.
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 FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a significant risk (loss of sterility in an IV product) aligns with a score of 4, especially given the potential for serious injury from non-sterile administration.
Plain-English summary
Hospira Inc. is recalling 142,152 bags of Heparin Sodium in 5% Dextrose Injection, 25,000 USP Heparin Units/250 mL. The recall is being conducted due to a lack of assurance of sterility, triggered by a confirmed consumer report of fluid leaking from the primary container of the bag.
The affected product is distributed nationwide. Specific lots involved include 34-811-KL, 36-106-KL, 36-114-KL, 36-101-KL, 37-202-KL, and 38-302-KL, with expiration dates ranging from December 2015 to February 2016. The product is identified by NDC 0409-7793-62 and is administered intravenously.
Consumers and healthcare providers should stop using the affected lots and contact Hospira Inc. or their local FDA office for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- HEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM AND DEXTROSE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Affected units
- 142,152
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 (10)
- Lot # 34-811-KL
- 36-106-KL
- 36-114-KL
- Exp. 12/15
- 36-101-KL
- 37-202-KL
- Exp. 1/16
- 38-302-KL
- Exp. 2/16
- 38-305-KL
Distribution
Distributed nationwide across the United States.
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