Labetalol Hydrochloride Injection, Solution
FDA Recall NDC 0409-2267
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Labetalol Hydrochloride (NDC 0409-2267). A significant event, classified as Class II, was initiated on Feb 20, 2018 by Hospira, Inc.. The reported reason for this action was: "Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Feb 20, 2018
Mar 14, 2018
a) 137,975 vials; b) 40,143 vials
Recall Profile & Regulatory Data
Event ID
79238
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc. A Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Apr 02, 2020
Product Description
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.
Batch or Lot Expiration Information
Lot# Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
Affected Packages Involved in this Recall
0409-2267-20Product
0409-2267-54Product
0409-0125-01Product
0409-0125-25Product
0409-2267-25Product
May 2014 Class II Recall: Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Recall Number
Class II Terminated
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
May 16, 2014
Jul 16, 2014
45,448 vials
Recall Profile & Regulatory Data
Event ID
68296
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 16, 2017
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
Batch or Lot Expiration Information
Lot# Lot 36225DD, exp 12/01/2015
Affected Packages Involved in this Recall
0409-2267-20Product
0409-2267-54Product
0409-0125-01Product
0409-0125-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
