FDA-Drug2018-03-14Class II
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.
Hospira Inc. A Pfizer Company
Hazard
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
a) 137,975 vials; b) 40,143 vials
Manufactured in
1776 Centennial Dr, N/A, Mcpherson, KS, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2018Don't want to check this manually?
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