Hospira Recalls Dobutamine in Dextrose Injection Due to Sterility Concerns
Hospira Inc. is recalling 44,748 bags of Dobutamine in Dextrose Injection because a confirmed leak in the primary container raises concerns about 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 recall as Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (leaking container compromising sterility) align with a score of 4 (Severe), as the agency's own classification mandates a score of at least 4 for Class I/II drug recalls involving significant risks.
Plain-English summary
Hospira Inc. is voluntarily recalling 44,748 bags of DOBUTAMINE in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag. The recall is being conducted due to a confirmed report of leaking in the primary container, which creates a lack of assurance of sterility for the affected product.
The affected product is identified by Lot 11-309-KL and NDC 0409-2346-32. The recall covers distribution nationwide and in Puerto Rico. This is a prescription-only intravenous medication manufactured by Hospira, Inc. in Lake Forest, Illinois.
Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the manufacturer for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DOBUTAMINE IN DEXTROSE (DOBUTAMINE IN DEXTROSE)
- Brand
- DOBUTAMINE IN DEXTROSE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 44,748
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 (1)
- Lot 11-309-KL
Distribution
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