FDAClass IIJuly 16, 2014

Labetalol Hydrochloride Injection recall: Particulate Matter

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake…

Why was Labetalol Hydrochloride Injection recalled?

Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 36225DD, exp 12/01/2015

Product
Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake…
Recalling firm
Hospira Inc.
Quantity
45,448 vials
Distribution
Nationwide
Recall date
July 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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