FDA-Drug2021-02-17Class III

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

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Impurity/Degradation Specifications

Sold states
Nationwide
Affected count
20,475 vials
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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

Official notice

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

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