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

FDA recall notice · announced February 17, 2021 · Sun Pharmaceutical Industries

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
Quantity: 20,475 vials
Status: Terminated
Products in this recall event:
- 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-Baro (D-0251-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.