Class III
Terminated
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
This recall has been terminated (originally issued February 17, 2021).
- Recall Initiated
- February 5, 2021
- Posted
- February 17, 2021
- Recall Number
- D-0251-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,475 vials
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution
Nationwide
Lot / Code Info
JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
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