Hospira Recalls Labetalol Hydrochloride Injection Due to Particulate Matter
Hospira Inc. is recalling Labetalol Hydrochloride Injection due to the presence of particulate matter, including metal embedded in glass vials and visible particles in the solution.
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 recall is classified as FDA Class II, and the presence of metal embedded in glass vials and visible particles in an intravenous solution represents a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
Hospira Inc. is recalling Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial. The recall involves 45,448 vials distributed nationwide. The specific lot affected is 36225DD, with an expiration date of 12/01/2015. The product is identified by NDC 0409-2267-20.
The recall was initiated because of the presence of particulate matter. Specifically, metal was found embedded in the glass vials, and visible particles were observed floating in the solution. This defect poses a risk to patients receiving the intravenous medication.
Healthcare providers and patients should stop using the affected lot of Labetalol Hydrochloride Injection. Consumers and medical facilities should check their inventory for Lot 36225DD and contact Hospira Inc. or their local FDA office for further instructions on how to return or dispose of the product.
The recalled product
- Product
- LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
- Brand
- LABETALOL HYDROCHLORIDE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 45,448
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 36225DD
- exp 12/01/2015
Distribution
Distributed nationwide across the United States.
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