Medications & Supplements/Prescription Drugs

Glenmark Deferasirox Tablets Recalled for Failed Dissolution

Agency Publication Date: November 8, 2023

Summary

Glenmark Pharmaceuticals Inc., USA is recalling 5,856 bottles of Deferasirox Tablets for Oral Suspension (500mg). Deferasirox is a prescription medication used to treat chronic iron overload in patients. This recall was issued because the tablets failed dissolution specifications, which means the drug may not dissolve and release the active ingredient as intended.

Risk

If the medication fails to dissolve properly, patients may not receive the full therapeutic dose. This can lead to inconsistent treatment of iron overload, potentially reducing the effectiveness of the therapy.

What You Should Do

This recall affects Glenmark brand Deferasirox Tablets for Oral Suspension (500mg) sold in 30-count bottles with NDC 68462-496-30.
Identify your product by checking the lot number and expiration date on the bottle label. Affected lots include: 17220063 (Exp 12/2023); 17220396 and 17220397 (Exp 01/2024); 17220965 (Exp 04/2024); 17221187 and 17221523 (Exp 07/2024); and 17221793, 17221794, and 17221801 (Exp 08/2024).
If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Deferasirox Tablets for Oral Suspension, 500mg (30-count bottle)by Glenmark

Variants: 500mg, Tablets for Oral Suspension

Lot Numbers:

17220063 (Exp 12/2023)

17220396 (Exp 01/2024)

17220397 (Exp 01/2024)

17220965 (Exp 04/2024)

17221187 (Exp 07/2024)

17221523 (Exp 07/2024)

17221793 (Exp 08/2024)

17221794 (Exp 08/2024)

17221801 (Exp 08/2024)

NDC:

68462-496-30

Quantity affected: 5,856 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93219

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Retail Pharmacies

Manufactured In: India

Units Affected: 5,856 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

This recall affects Glenmark brand Deferasirox Tablets for Oral Suspension (500mg) sold in 30-count bottles with NDC 68462-496-30.

Identify your product by checking the lot number and expiration date on the bottle label. Affected lots include: 17220063 (Exp 12/2023); 17220396 and 17220397 (Exp 01/2024); 17220965 (Exp 04/2024); 17221187 and 17221523 (Exp 07/2024); and 17221793, 17221794, and 17221801 (Exp 08/2024).

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Deferasirox Tablets for Oral Suspension, 500mg (30-count bottle)by Glenmark

Variants: 500mg, Tablets for Oral Suspension

Lot Numbers:

17220063 (Exp 12/2023)

17220396 (Exp 01/2024)

17220397 (Exp 01/2024)

17220965 (Exp 04/2024)

17221187 (Exp 07/2024)

17221523 (Exp 07/2024)

17221793 (Exp 08/2024)

17221794 (Exp 08/2024)

17221801 (Exp 08/2024)

NDC:

68462-496-30

Quantity affected: 5,856 bottles