February 2021 FDA Recall Pantoprazole Sodium by Sun Pharmaceutical Industries Inc
D-0251-2021 - Failed Impurity/Degradation Specifications

This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on February 5, 2021 for the product Pantoprazole Sodium. The FDA reported the reason for recall as failed impurity/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0251-2021

Reason for Recall
Failed Impurity/Degradation Specifications
Initiated
02-05-2021
Reported
02-17-2021
Quantity
20,475 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87260
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-03-2021
Product Description About Product Description
Full technical description of the product.
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

62756-129-40 Pantoprazole Sodium
62756-129-44 Pantoprazole Sodium
62756-129-45 Pantoprazole Sodium