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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

Boehringer Ingelheim Pharmaceuticals, Inc.: Catapres .2 (clonidine hydrochloride) Recalled for Failed Dissolution

Agency Publication Date: October 31, 2018
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Summary

Boehringer Ingelheim Pharmaceuticals, Inc. has recalled approximately 1,380 bottles of Catapres .2 (clonidine hydrochloride, USP) 0.2mg tablets, a prescription medication used to treat high blood pressure. The recall was initiated because routine stability testing showed the tablets failed dissolution specifications, meaning the drug may not dissolve properly in the body as intended. This defect could potentially lead to inconsistent absorption of the medication, affecting its efficacy in managing blood pressure. Consumers who have these specific 100-count bottles should consult their healthcare provider or pharmacist.

Risk

If the medication fails to dissolve properly, the body may not receive the correct dose of clonidine hydrochloride at the right time. This can lead to ineffective control of high blood pressure, potentially causing a patient's blood pressure to rise unexpectedly.

What You Should Do

  1. Identify your medication by checking the bottle for 'Catapres .2 (clonidine hydrochloride, USP) 0.2mg' in 100-count bottles with NDC 0597-0007-01.
  2. Check the bottle label for lot number 757739 and an expiration date of September 2020 (EXP 9/2020).
  3. If you have the affected medication, do not stop taking it until you have spoken with your healthcare provider or pharmacist, as stopping blood pressure medication abruptly can be dangerous.
  4. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement and return any unused product to the pharmacy for a refund.
  5. Contact Boehringer Ingelheim Pharmaceuticals, Inc. at their Ridgefield, CT location for further instructions regarding this recall.
  6. 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

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: Catapres .2 (clonidine hydrochloride, USP) 0.2mg (100-count bottle)
Model:
NDC 0597-0007-01
Recall #: D-0128-2019
Lot Numbers:
757739 (EXP 9/2020)
Date Ranges: EXP 9/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81340
Status: Resolved
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: Germany, United States
Units Affected: 1,380 100-count bottles
Distributed To: Nationwide
Agency Last Updated: November 2, 2018

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.