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) 74370DDExp 1FEB201975035DD75115DDExp 1MAR2019b) 74230DDExp 1FEB2019
- Lots
- 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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