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Chlorthalidone Recall: FDA Flags Second India-Made Blood Pressure Drug

Chlorthalidone Recall: FDA Flags Second India-Made Blood Pressure

More than 11,000 bottles of the blood pressure medication <span>Chlorthalidone</span>, manufactured in India, have been recalled in the United States, according to the Food and Drug Administration (<span>FDA</span>). This is the second India-made blood pressure drug to be recalled in over a month.

Mumbai-based manufacturer <span>Inventia Healthcare Limited</span> recalled the prescription-only Chlorthalidone Tablets USP, 25 mg on June 5 due to "failed dissolution specifications." This means that the tablets may not break down correctly in the body. The drug is sold under several brand names, including <span>Thalitone</span> and Hygroton, and is distributed in America by New Jersey-based Rising Pharma Holdings.

<h2>What Is Chlorthalidone Used For?</h2>

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Chlorthalidone is a diuretic, or "water pill," prescribed to treat high blood pressure and fluid retention associated with conditions such as congestive heart failure, kidney disease, and liver disease.

It works by helping the kidneys eliminate excess water and salt through urine.

The FDA has not yet classified the recall or detailed the potential health consequences for patients.

<h2>What Does Dissolution Of A Drug Mean?</h2>

Dissolution refers to the process by which a tablet breaks down and releases its active ingredient into the body after it is taken.

A dissolution failure means that, during regulatory testing, the tablets did not dissolve as required. As a result, the active ingredient may not be released properly, potentially reducing the amount of medicine that reaches the bloodstream and works as intended, according to Cardiovascular Business..

Dissolution problems can arise from several factors, including poor formulation design, manufacturing process issues, low-quality raw materials, or stability issues that affect the product over time.

<h2>Which Medication Has Been Recalled?</h2>

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According to the FDA, 11,460 bottles of Chlorthalidone are included in the recall and carry an expiration date of April 2027.

<ul><li>100-tablet bottles marked with batch RISA24001</li><li>1,000-tablet bottles marked with batch RISB24002</li></ul>

<h2>Second <span rel="noindex">BP Drug Recall</span></h2>

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The recall follows another <span>FDA recall</span> announced on May 5 involving Amlodipine and Olmesartan Medoxomil Tablets (5 mg/40 mg), another prescription blood pressure medication.

A total of 15,696 bottles were recalled due to "failed dissolution specifications: Olmesartan Medoxomil content below specifications."

The medication was also manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC, Parsippany, New Jersey. The recalled bottles carry an expiration date of October 31, 2027.

<h2>Previous Large-Scale Blood Pressure Drug Recall</h2>

The latest recall follows a separate large-scale blood pressure medication recall in October, when manufacturers recalled more than 500,000 bottles of Prazosin Hydrochloride due to contamination concerns.

That recall involved potential contamination with unsafe levels of a cancer-causing chemical, prompting the manufacturer to advise patients to consult their physicians or pharmacists.

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More than 11,000 bottles of the blood pressure medication Chlorthalidone, manufactured in India, have been recalled in the United States, according to the Food and Drug Administration (FDA). This is the second India-made blood pressure drug to be recalled in over a month.Mumbai-based manufacturer Inventia Healthcare Limited recalled the prescription-only Chlorthalidone Tablets USP, 25 mg on June 5 due to "failed dissolution specifications." This means that the tablets may not break down correctly in the body. The drug is sold under several brand names, including Thalitone and Hygroton, and is distributed in America by New Jersey-based Rising Pharma Holdings.What Is Chlorthalidone Used For?Also read: Robert F. Kennedy Jr. Launches Reforms To Speed Up Early Drug Research In USChlorthalidone is a diuretic, or "water pill," prescribed to treat high blood pressure and fluid retention associated with conditions such as congestive heart failure, kidney disease, and liver disease.It works by helping the kidneys eliminate excess water and salt through urine.The FDA has not yet classified the recall or detailed the potential health consequences for patients. What Does Dissolution Of A Drug Mean?Dissolution refers to the process by which a tablet breaks down and releases its active ingredient into the body after it is taken.A dissolution failure means that, during regulatory testing, the tablets did not dissolve as required. As a result, the active ingredient may not be released properly, potentially reducing the amount of medicine that reaches the bloodstream and works as intended, according to Cardiovascular Business..Dissolution problems can arise from several factors, including poor formulation design, manufacturing process issues, low-quality raw materials, or stability issues that affect the product over time.Which Medication Has Been Recalled?Also read: US FDA Panel Recommends First-Ever mRNA Flu Shot For Older Adults: All About The Moderna VaccineAccording to the FDA, 11,460 bottles of Chlorthalidone are included in the recall and carry an expiration date of April 2027.The recall affects:100-tablet bottles marked with batch RISA240011,000-tablet bottles marked with batch RISB24002Second BP Drug RecallRead More: 4 Indian States Roll Out IV Iron Therapy To Curb Anemia In Pregnant Women: How It WorksThe recall follows another FDA recall announced on May 5 involving Amlodipine and Olmesartan Medoxomil Tablets (5 mg/40 mg), another prescription blood pressure medication.A total of 15,696 bottles were recalled due to "failed dissolution specifications: Olmesartan Medoxomil content below specifications."The medication was also manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC, Parsippany, New Jersey. The recalled bottles carry an expiration date of October 31, 2027.Both recalls were issued nationwide.Previous Large-Scale Blood Pressure Drug RecallThe latest recall follows a separate large-scale blood pressure medication recall in October, when manufacturers recalled more than 500,000 bottles of Prazosin Hydrochloride due to contamination concerns.That recall involved potential contamination with unsafe levels of a cancer-causing chemical, prompting the manufacturer to advise patients to consult their physicians or pharmacists.

chlorthalidone recall: fda flags second india-made blood pressure drug

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