Drug 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
D-0251-2021
Product summary
- Event
- Event 87260
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20,475 vials
- Official record key
drug-enforcement:D-0251-2021
Official wording
Reason: Failed Impurity/Degradation Specifications
Code information: JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications