Medications & Supplements/Prescription Drugs

Camber Pantoprazole Sodium Delayed Release Tablets Recalled for Discoloration

Agency Publication Date: April 11, 2023

Summary

Approximately 2,352 bottles of Camber brand Pantoprazole Sodium (pantoprazole sodium) Delayed Release Tablets USP 40mg are being recalled because the tablets may be discolored. This discoloration indicates the tablets were not manufactured according to required quality standards. The recall affects 1000-count bottles that were manufactured by Hetero Labs Limited and distributed nationwide.

Risk

Discolored tablets indicate a quality failure that could potentially affect the medication's effectiveness or safety for patients treating stomach or esophagus conditions.

What You Should Do

The recalled products are 1,000-count bottles of Camber brand Pantoprazole Sodium Delayed Release Tablets USP 40mg (NDC 31722-713-10) from lot number PAN22542 with an expiration date of 9/2024.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Hetero USA Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an issue.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pantoprazole Sodium Delayed Release Tablets USP 40mg (1000-count bottles)by Camber Pharmaceuticals Inc.

Variants: 40mg, Delayed Release Tablets

Lot Numbers:

PAN22542 (Exp. Date: 9/2024)

NDC:

31722-713-10

Recall #: D-0530-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91855

Status: Active

Manufacturer: Hetero USA Inc

Sold By: Camber Pharmaceuticals Inc.

Manufactured In: India, United States

Units Affected: 2,352 bottles

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 · 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.

Summary

What You Should Do

The recalled products are 1,000-count bottles of Camber brand Pantoprazole Sodium Delayed Release Tablets USP 40mg (NDC 31722-713-10) from lot number PAN22542 with an expiration date of 9/2024.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Hetero USA Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an issue.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.