FDA recall D-0251-2021

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 for recall

Failed Impurity/Degradation Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2021-02-05

Report date

2021-02-17

Termination date

2021-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2021