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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pantoprazole Sodium for Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: September 11, 2023
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Summary

BE PHARMACEUTICALS AG is recalling 41,148 vials of Pantoprazole Sodium for Injection (40mg) due to a lack of sterility assurance. The recall was initiated because small cracks were found in some vials, causing the powder inside to become discolored. No incidents or injuries have been reported to date in connection with this issue.

Risk

A crack in a vial can compromise its sterile seal, potentially allowing bacteria or other contaminants to enter the medication. Injecting a drug that is not sterile poses a high risk of causing serious, life-threatening infections.

What You Should Do

  1. This recall affects Pantoprazole Sodium for Injection (40mg per vial) packaged in single-dose vials under NDC 71839-122-01, and multi-vial cartons under NDCs 71839-122-10 and 71839-122-25.
  2. Identify the affected product by checking the lot number and expiration date printed on the vial or outer carton. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact BE Pharmaceuticals AG or your distributor to arrange for the return of the affected medication.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Pantoprazole Sodium for Injection (40mg per vial)
Variants: 40mg per vial, Single-dose vial, 10-count carton, 25-count carton
Lot Numbers:
GSC04002A (Exp Mar-2024)
GSC04003A (Exp Mar-2024)
GSC04004A (Exp Mar-2024)
GSC04006A (Exp Mar-2024)
GSC05001A (Exp April-2024)
GSC05006A (Exp April-2024)
GSC05007A (Exp April-2024)
GSC10003A (Exp Sep-2024)
GSC10005A (Exp Sep-2024)
GSC06004A (Exp May-2024)
GSC06005A (Exp May-2024)
GSC07001A (Exp Jun-2024)
GSC07007A (Exp Jun-2024)
GSC07008A (Exp Jun-2024)
GSC07009A (Exp Jun-2024)
GSC08001A (Exp Jul-2024)
GSC05009A (Exp Apr-2024)
GSC04005A (Exp Mar-2024)
GSC06003A (Exp May-2024)
GSC10001A (Exp Sep-2024)
GSC07006A (Exp Jun-2024)
GSC08002A (Exp Jul-2024)
GSD02012A (Exp Jan-2025)
GSD03005A (Exp Feb-2025)
GSD03008A (Exp Feb-2025)
NDC:
71839-122-01
71839-122-10
71839-122-25

Rx Only medication manufactured in Switzerland and India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92968
Status: Resolved
Manufacturer: BE PHARMACEUTICALS AG
Sold By: BE Pharmaceuticals Inc.; medical wholesalers; hospitals
Manufactured In: Switzerland, India
Units Affected: 41,148 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.