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Class II: temporary or reversible health riskTerminated

Hospira Labetalol Hydrochloride Injection Recall

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, p…

Hospira Inc. · Lake Forest, IL

Risk level
Class II
Reported by FDA
Jul 16, 2014
Recall ID
D-1424-2014
Check your lot numberHow we source this data

Summary

Hospira recalled Labetalol Hydrochloride Injection starting May 16, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1424-2014 on Jul 16, 2014. Reason: Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution. Status: Terminated.

Why it was recalled

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

Product description

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 Forest, IL 60045 --- NDC 0409-2267-20

Lot numbers, UPCs & expiration codes

Lot 36225DD, exp 12/01/2015

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1424-2014
Classification
Class II
Status
Terminated
Recall initiated
May 16, 2014
FDA report date
Jul 16, 2014
Quantity
45,448 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-1424-2014, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
68296
Address
275 N Field Dr
Code information
Lot 36225DD, exp 12/01/2015
Postal code
60045-2579
Report date
Jul 16, 2014
Product type
Drugs
Recall number
D-1424-2014
Classification
Class II
Recalling firm
Hospira Inc.
Product quantity
45,448 vials
Termination date
Mar 16, 2017
Reason for recall
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Voluntary / mandated
Voluntary: Firm initiated
Product description
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 Forest, IL 60045 --- NDC 0409-2267-20
Distribution pattern
Nationwide
Recall initiation date
May 16, 2014
Initial firm notification
Press Release
Center classification date
Jul 8, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1424-2014, published Jul 16, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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