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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

H J Harkins Company Inc dba Pharma Pac: Valsartan Tablets Recalled Due to Carcinogen Impurity

Agency Publication Date: August 1, 2018
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Summary

Pharma Pac has recalled 540 tablets (six 90-count bottles) of Valsartan (160 mg), a medication used to treat high blood pressure, because a carcinogen impurity was detected in the active ingredient used to manufacture the drug. This recall affects specific repackaged bottles that were distributed to a physician's office. The affected tablets are yellow, capsule-shaped, and are marked with "343" and "HH". If you are taking this medication, you should contact your doctor or pharmacist for a replacement before you stop taking the drug, as stopping blood pressure medication suddenly can be dangerous.

Risk

The medication contains an impurity classified as a probable human carcinogen, which may increase the risk of cancer with long-term exposure. No specific injuries or adverse health events have been reported in connection with this specific recall.

What You Should Do

  1. Check your medication bottle for Valsartan 160 mg (90-count) repackaged by H.J. Harkins Co, Inc. with NDC 43547-0369-09.
  2. Identify if your bottle is marked with lot number VSA000OV or manufacturer's lot 343B17015, both with an expiration date of 02/19.
  3. Confirm the appearance of the tablets: they should be yellow, capsule-shaped, and debossed with '343' on one side and 'HH' on the other.
  4. Contact your healthcare provider or pharmacist immediately to obtain a replacement or alternative treatment; do not stop taking your current medication until you have a replacement, as the risk of untreated high blood pressure may outweigh the risk of the impurity.
  5. Return any unused product to the physician's office where you received it for a refund and contact H J Harkins Company Inc dba Pharma Pac for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

How to: Return the unused medication to the physician's office or place of purchase for a refund and consult a healthcare professional for a replacement prescription.

Affected Products

Product: Valsartan tablets 160 mg (90-count bottle)
Model:
NDC 43547-0369-09
Lot Numbers:
VSA000OV (Exp 02/19)
343B17015 (Exp 02/19)
Date Ranges: Expiration date 02/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80674
Status: Resolved
Manufacturer: H J Harkins Company Inc dba Pharma Pac
Sold By: Physician's office
Manufactured In: United States
Units Affected: 540 tablets
Distributed To: 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.