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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

UNICHEM PHARMACEUTICALS USA INC: Clonidine Hydrochloride Tablets Recalled for Potential Chemical Contamination

Agency Publication Date: June 8, 2020
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Summary

Unichem Pharmaceuticals is recalling 190,992 bottles of Clonidine Hydrochloride Tablets USP 0.1 mg (a blood pressure medication). The recall was initiated because very low levels of a chemical called benzophenone may have leaked from the container into the tablets, causing the product to fail purity and quality standards. This voluntary recall affects 100-count bottles that were distributed nationwide throughout the United States.

Risk

The tablets may contain trace amounts of benzophenone, an impurity that migrated from the packaging material into the medicine. While the levels are reported as very low, the presence of this unintended chemical means the medication does not meet the strict safety and quality specifications required for pharmaceutical products.

What You Should Do

  1. Check your medication bottle to see if it is Clonidine Hydrochloride Tablets USP 0.1 mg, 100-count bottles, with NDC 29300-135-01.
  2. Verify if your bottle matches one of the following lot numbers and expiration dates: Lot GCLL19034 (Exp. 4/30/2021), Lot GCLL19035 (Exp. 4/30/2021), Lot GCLL19036 (Exp. 4/30/2021), or Lot GCLL19044 (Exp. 6/30/2021).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are taking this medication. Do not stop taking your blood pressure medication without consulting a professional first.
  4. Return any unused product from the affected lots to your pharmacy for a refund.
  5. Contact Unichem Pharmaceuticals USA Inc. at their East Brunswick, NJ office or via their customer service channels for further instructions regarding this recall.
  6. For additional questions or to report a problem, 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

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

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

Affected Products

Product: Clonidine Hydrochloride Tablets, USP 0.1 mg (100-count bottle)
Model:
NDC 29300-135-01
Lot Numbers:
GCLL19034 (Exp. 4/30/2021)
GCLL19035 (Exp. 4/30/2021)
GCLL19036 (Exp. 4/30/2021)
GCLL19044 (Exp. 6/30/2021)
Date Ranges: Exp. 4/30/2021, Exp. 6/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85764
Status: Resolved
Manufacturer: UNICHEM PHARMACEUTICALS USA INC
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 190,992 bottles
Distributed To: Nationwide
Agency Last Updated: June 23, 2020

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.