Medications & Supplements/Prescription Drugs

Torrent Pharma Inc.: Anagrelide Capsules Recalled Due to High Levels of Impurities

Agency Publication Date: September 16, 2019

Summary

Torrent Pharma Inc. is recalling 2,472 bottles of Anagrelide Capsules USP, 0.5 mg (generic for Agrylin), a medication used to treat blood disorders. Routine stability testing detected high levels of impurities that were out of specification, which could affect the quality and safety of the medication. Affected bottles contain 100 capsules and were distributed nationwide across the United States and Puerto Rico.

Risk

The presence of elevated impurities or degradation products means the medication may not meet required safety and purity standards over time, potentially leading to reduced effectiveness or unintended side effects.

What You Should Do

Check your medication bottle for NDC 13668-453-01 and Lot number BFE2E003 with an expiration date of 08/31/2020.
If your bottle matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement.
Do not stop taking your prescribed medication until you have spoken with a healthcare professional to ensure your condition remains managed.
Return any unused capsules from the affected lot to your pharmacy for a refund.
Contact Torrent Pharma Inc. at their Basking Ridge, NJ office for further instructions regarding this recall.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy-level refund and medical consultation.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Anagrelide Capsules, USP, 0.5 mg (100-count bottle)

Model:

NDC 13668-453-01

Recall #: D-1862-2019

Lot Numbers:

BFE2E003 (Exp 08/31/2020)

Date Ranges: Exp 08/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83733

Status: Resolved

Manufacturer: Torrent Pharma Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2472 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

Check your medication bottle for NDC 13668-453-01 and Lot number BFE2E003 with an expiration date of 08/31/2020.

If your bottle matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement.

Do not stop taking your prescribed medication until you have spoken with a healthcare professional to ensure your condition remains managed.

Return any unused capsules from the affected lot to your pharmacy for a refund.

Contact Torrent Pharma Inc. at their Basking Ridge, NJ office for further instructions regarding this recall.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.