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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

NuCare Pharmaceuticals Inc: Valsartan/HCTZ Tablets Recalled for Carcinogen Impurity

Agency Publication Date: August 3, 2018
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Summary

NuCare Pharmaceuticals has recalled various strengths of Valsartan/HCTZ (valsartan and hydrochlorothiazide) prescription tablets packaged in 30-count and 90-count jars. This recall was initiated because the active ingredient used to manufacture these blood pressure medications was found to contain a carcinogenic impurity. Consumers who have these medications should not stop taking them without first consulting their healthcare provider or pharmacist, as the risk of stopping the medication suddenly may be greater than the risk of the impurity.

Risk

The medication contains an active pharmaceutical ingredient that was found to have a carcinogen impurity, which is a substance that could potentially cause cancer with long-term exposure.

What You Should Do

  1. Check your prescription bottle for the following product names and lot numbers: Valsartan/HCTZ 160/12.5 mg (Lot U01779, Exp. 04/30/2019), Valsartan/HCTZ 160/25 mg (Lot T11443, Exp. 02/28/2019), or Valsartan/HCTZ 320/25 mg (Lot T11577, Exp. 06/30/2019).
  2. Verify the National Drug Code (NDC) on the label: 68071-4311-9 for the 160/12.5 mg strength or 68071-4183-3 for the 320/25 mg strength.
  3. Do NOT stop taking your medication until you have spoken with your doctor or pharmacist. They can provide a replacement or alternative treatment to ensure your blood pressure remains managed.
  4. Contact your pharmacy to return any unused portions of the affected lots for a refund and to discuss the next steps for your prescription.
  5. Contact NuCare Pharmaceuticals at their Orange, CA location or your healthcare provider if you have experienced any problems that may be related to taking this drug.
  6. For further 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

๐Ÿ’ฐFull Refund

Guidance and refund for unused medication

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

Affected Products

Product: Valsartan/HCTZ 160/12.5 mg Tablets (90-count jar)
Model:
NDC 68071-4311-9
Lot Numbers:
U01779 (Exp. 04/30/2019)
Date Ranges: Exp. 04/30/2019
Product: Valsartan/HCTZ 160/25mg Tablets (30-count jar)
Lot Numbers:
T11443 (Exp. 02/28/2019)
Date Ranges: Exp. 02/28/2019
Product: Valsartan/HCTZ 320/25mg Tablets (30-count jar)
Model:
NDC 68071-4183-3
Lot Numbers:
T11577 (Exp. 06/30/2019)
Date Ranges: Exp. 06/30/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80701
Status: Resolved
Manufacturer: NuCare Pharmaceuticals Inc
Manufactured In: United States
Distributed To: Florida, California

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.