PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 17, 2021 Initiated: February 5, 2021 #D-0251-2021

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

Reason for Recall

Failed Impurity/Degradation Specifications

Details

Units Affected
20,475 vials
Distribution
Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 20,475 vials.
Why was this product recalled?
Failed Impurity/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 17, 2021. Severity: Low. Recall number: D-0251-2021.