FDAFDA · Food and drugs·Recall number D-0340-2018
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
Published February 14, 2018 · Recall initiated: December 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Product was distributed nationwide in the USA
- Lot
- Lot # CPO170035
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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