Recall: D-0251-2021

Class III - Minor Violations

Class IIIClassification

2021-02-05Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.