Pantoprazole Sodium for Injection 40mg/vial For I.V…

Date

Feb. 17, 2021

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

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

Reason

Failed Impurity/Degradation Specifications

Distribution pattern

Nationwide

Quantity

20,475 vials

Codes and lots

JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021

Recall started

Feb. 5, 2021

Recall number

D-0251-2021

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0251-2021. The agency record governs; check it and the company before acting.