Labetalol Hydrochloride Injection, Solution
FDA Recall NDC 0409-2339
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Labetalol Hydrochloride (NDC 0409-2339). A significant event, classified as Class II, was initiated on May 20, 2024 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility-The potential for incomplete crimp seals."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
May 2024 Class II Recall: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recall Number
Class II Ongoing
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
May 20, 2024
Jul 03, 2024
220,400 cartridges
Recall Profile & Regulatory Data
Event ID
94681
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide and Puerto Rico.
Product Description
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
Batch or Lot Expiration Information
Lot# : HJ7566; Exp 2025/05
Lot# : HN8747; Exp 2025/09
Lot# : HN8749; Exp 2025/09
Affected Packages Involved in this Recall
0409-2339-24Product
0409-2339-34Product
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.
