Pantoprazole Sodium for Injection 40mg/vial For I.V. recall: Impurity Out of Spec
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
Why was Pantoprazole Sodium for Injection 40mg/vial For I.V. recalled?
Failed Impurity/Degradation Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
- 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
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 20,475 vials
- Distribution
- Nationwide
- Recall date
- February 17, 2021
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)