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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # CPO170035
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AuroMedics Pharma LLC
- Reason for Recall:
- Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot # CPO170035
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0340-2018
Related Recalls
Class I - Dangerous
Subpotent Drug: Out of specification for assay
Class I - Dangerous
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class I - Dangerous
Presence of Particulate Matter: Piece of metal found in a vial