Clonidine Injection, Solution
FDA Recall NDC 39822-2000
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 Clonidine (NDC 39822-2000). A significant event, classified as Class III, was initiated on Mar 29, 2019 by Xgen Pharmaceuticals Djb, Inc.. The reported reason for this action was: "Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL."
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 III Terminated
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Mar 29, 2019
Apr 17, 2019
24,966 vials
Recall Profile & Regulatory Data
Event ID
82504
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
X-Gen Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jun 02, 2021
Product Description
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
Batch or Lot Expiration Information
Lot# Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020
Affected Packages Involved in this Recall
39822-2000-1Product
39822-2010-1Product
Class III Terminated
Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Jul 17, 2014
Jul 30, 2014
8,356 vials
Recall Profile & Regulatory Data
Event ID
68729
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
X-Gen Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 07, 2015
Product Description
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.
Batch or Lot Expiration Information
Lot# Lot: PLNB1412, Exp 12/15
Affected Packages Involved in this Recall
39822-2000-1Product
39822-2010-1Product
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.
