Reported Mar 14, 2018 · Terminated

Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira,…

Hospira Inc. A Pfizer Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hospira Inc. A Pfizer Company · 1776 Centennial Dr · Mcpherson, KS · 67460-9301

Is this the product you have?

  • Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.
Lot codes and dates
  • Lots
    • a) 74370DD
    • Exp 1FEB2019
    • 75035DD
    • 75115DD
    • Exp 1MAR2019
    • b) 74230DD
    • Exp 1FEB2019
Amount recalled
a) 137,975 vials; b) 40,143 vials

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 2, 2020 · Data as of Sep 19, 5:53 PM UTC

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