Hospira Recalls Dobutamine Injection Vials Due to Glass Particulate Matter
Hospira Inc. is recalling 123,900 vials of Dobutamine Injection due to the presence of glass particulate matter and a discolored solution.
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 per the rubric, as it represents a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Hospira Inc. is recalling 123,900 vials of DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial. The product is identified by Lot # 27-352-DK with an expiration date of 03/15 and NDC 0409-2344-02. The recall was initiated because of the presence of particulate matter, specifically glass particulate found within the solution, and a discolored solution caused by a chip in the glass at the neck of the vial.
The affected product was distributed nationwide and in Puerto Rico. This is a prescription-only intravenous medication manufactured for Hospira Inc. in Lake Forest, IL.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or replacement. Consumers should not use the product if they notice any particulate matter or discoloration in the solution.
The recalled product
- Product
- DOBUTAMINE (DOBUTAMINE)
- Brand
- DOBUTAMINE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 123,900
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 # 27-352-DK
- Exp 03/15
Distribution
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