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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Methapharm Pantoprazole Sodium for Injection Recalled for CGMP Deviations

Agency Publication Date: April 21, 2023
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Summary

Methapharm Inc. is recalling 5,377 cartons of Pantoprazole sodium for Injection (40 mg/vial), a medication used to treat conditions involving excess stomach acid. The recall was issued because certain lots were inadvertently placed into saleable inventory in violation of approved manufacturing procedures (CGMP deviations). No injuries or incidents have been reported in connection with this product, which was distributed to hospitals, clinics, and pharmacies.

Risk

Products released into inventory outside of approved procedures may not meet quality and safety standards. While no specific harm has been reported, deviations from manufacturing protocols pose a potential risk to patients receiving the injection.

What You Should Do

  1. This recall affects Methapharm Pantoprazole sodium for Injection 40 mg/vial, sold in single-dose vials with NDC 67850-150-10 (carton) and NDC 67850-150-00 (vial).
  2. Check your inventory for lot numbers 220801, 220802, or 220803, all with an expiration date of July 2024.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange for the return of any affected units.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information or to report concerns.

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 (40 mg/vial)
Variants: 40 mg/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only
Lot Numbers:
220801 (Exp. July 2024)
220802 (Exp. July 2024)
220803 (Exp. July 2024)
NDC:
67850-150-10
67850-150-00

Quantity: 5377 cartons

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92113
Status: Resolved
Manufacturer: Methapharm Inc
Sold By: hospitals; clinics; pharmacies
Manufactured In: United States
Units Affected: 5377 cartons
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.