Why it was recalled
Failed Impurity/Degradation Specifications
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
Lot numbers, UPCs & expiration codes
JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0251-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 5, 2021
- FDA report date
- Feb 17, 2021
- Quantity
- 20,475 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0251-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87260
- Address
- 2 Independence Way
- Code information
- JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
- Postal code
- 08540-6620
- Report date
- Feb 17, 2021
- Product type
- Drugs
- Recall number
- D-0251-2021
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 20,475 vials
- Termination date
- Nov 3, 2021
- Reason for recall
- Failed Impurity/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 5, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2021