D-0251-2021 Class III Terminated
FDA drug recall D-0251-2021 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on February 5, 2021 and is designated Class III. Reason for recall: Failed Impurity/Degradation Specifications The recall status is terminated (terminated November 3, 2021). Affected quantity: 20,475 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 17, 2021
- Initiation Date
- February 5, 2021
- Termination Date
- November 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,475 vials
Product Description
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
Distribution Pattern
Nationwide
Code Information
JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021