Recalls / Class III
Class IIID-0251-2021
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
- Brand name
- Pantoprazole Sodium
- Generic name
- Pantoprazole Sodium
- Active ingredient
- Pantoprazole Sodium
- Route
- Intravenous
- NDC
- 62756-129
- FDA application
- ANDA077674
- Affected lot / code info
- JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
Why it was recalled
Failed Impurity/Degradation Specifications
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 20,475 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-02-05
- FDA classified
- 2021-02-09
- Posted by FDA
- 2021-02-17
- Terminated
- 2021-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0251-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.