Reported Feb 17, 2021 · Terminated
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc.…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Pantoprazole Sodium for Injection 40mg/vial For I.V
- infusion only Distributed bySun Pharmaceutical Industries, Inc. Cranbury
- NJ 08512 Manufactured bySun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
- Lot codes and dates
JKU3595AJKU3596AJKU3597Aand JKU3629AExp 02/2021
- Amount recalled
- 20,475 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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