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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

RemedyRepack Inc.: Amlodipine/Valsartan/HCTZ Tablets Recalled for NDMA Impurity

Agency Publication Date: August 28, 2018
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Summary

RemedyRepack Inc. is recalling three bottles of Amlodipine/Valsartan/HCTZ (10mg/320mg/25mg) tablets, a prescription medication used to treat high blood pressure. This recall affects approximately 270 tablets packaged in 90-count HDPE bottles. The recall was initiated because trace amounts of N-nitrosodimethylamine (NDMA) were detected in the active pharmaceutical ingredient; NDMA is a substance that could potentially cause cancer in humans. Consumers should contact their healthcare provider or pharmacist immediately to discuss alternative treatments before stopping the medication.

Risk

The medication contains trace amounts of NDMA, a known environmental contaminant and probable human carcinogen. Long-term exposure to levels of NDMA above acceptable limits may increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle for Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg tablets with NDC #70518-1220-0.
  2. Verify if your bottle belongs to Lot # B0476653-080218 with an expiration date of 08/2019.
  3. Do not stop taking the medication without first consulting your doctor or pharmacist, as stopping blood pressure medication abruptly can pose immediate health risks.
  4. Contact your healthcare provider or pharmacist for guidance on how to return the affected product and obtain a replacement or refund.
  5. Return any unused tablets in this specific lot to the pharmacy where you purchased them for a refund.
  6. Contact RemedyRepack Inc. at their facility in Indiana, PA, or visit the manufacturer Torrent Pharma LTD for further inquiries regarding this specific batch.
  7. For additional questions, contact 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

Healthcare guidance and product refund.

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

Affected Products

Product: Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet (90-count bottle)
Model:
70518-1220-0
Lot Numbers:
B0476653-080218 (Exp. 08/2019)
Date Ranges: 08/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80891
Status: Resolved
Manufacturer: RemedyRepack Inc.
Manufactured In: India, United States
Units Affected: 3 bottles of 90 tablets (270 tablets overall)
Distributed To: South Carolina

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.