Pantoprazole Sodium Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 62756-129
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 Pantoprazole Sodium (NDC 62756-129). A significant event, classified as Class III, was initiated on Feb 05, 2021 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Impurity/Degradation Specifications"
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
February 2021 Class III Recall: Failed Impurity/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurity/Degradation Specifications
Feb 05, 2021
Feb 17, 2021
20,475 vials
Recall Profile & Regulatory Data
Event ID
87260
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Nov 03, 2021
Product Description
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
Batch or Lot Expiration Information
Lot# JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
Affected Packages Involved in this Recall
62756-129-40Product
62756-129-44Product
62756-129-45Product
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.
