Blood pressure medication recalled nationwide under FDA’s Class II risk level

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1. 1h ago

   Nationwide Blood Pressure Medication Recalled Under FDA Class II

   Inventia Healthcare Limited is voluntarily recalling 13,567 bottles of chlorthalidone 25 mg tablets nationwide because the medication failed to meet the Food and Drug Administration dissolution testing specifications. The Food and Drug Administration classified the ongoing recall under its Class II risk level on September 17. The affected pills are used to lower blood pressure and may have also been prescribed to patients with heart failure, kidney disease, or cirrhosis of the liver. This marks the second time chlorthalidone tablets have been recalled this year due to dissolution test failures.

   Why it matters

   Dissolution testing ensures that the correct amount of active drug enters the bloodstream within a specified time. When medications fail these tests, patients may receive too little or too much of the active ingredient, posing health risks. The Class II designation is the second-highest level of risk used by the Food and Drug Administration, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

   What is confirmed

   • Inventia Healthcare Limited is voluntarily recalling 13,567 bottles of chlorthalidone 25 mg tablets nationwide.
   • The recall was triggered because the tablets failed to meet Food and Drug Administration dissolution testing specifications.
   • The Food and Drug Administration classified the ongoing recall as a Class II risk level on September 17.
   • Chlorthalidone tablets are used to treat high blood pressure and may be prescribed to those with heart failure, kidney disease, or liver cirrhosis.

   What to watch next

   • Further statements from Inventia Healthcare Limited regarding expanded recalls or affected lot numbers
   • Guidance from healthcare providers on whether patients should switch alternative medications
   Sources used for this update (11)

   1. The Hill — Blood pressure medication recalled nationwide under FDA’s Class II risk level
   2. WUSA9 — Blood pressure medication recalled nationwide after failing FDA dissolution testing
   3. Good Housekeeping — FDA Announces New Nationwide Blood Pressure Medication Recall
   4. newsnationnow.com — Blood pressure medication given Class II designation in recall update
   5. Newsday — Drug company recalls blood pressure medication chlorthalidone
   6. www.goodhousekeeping.com — FDA Announces New Nationwide Blood Pressure Medication Recall
   7. www.nbcchicago.com — FDA recalls more bottles of blood pressure medication – NBC ...
   8. ground.news — Blood pressure medication recalled nationwide under FDA’s ...
   9. www.yahoo.com — Blood Pressure Drug Recall Hits Nearly 14,000 Medicines in US Under FDA’s ‘Adverse Health Consequences’ Risk
   10. flipboard.com — FDA Updates Recalled Blood Pressure Medication to Second-Highest Level
   11. www.usatoday.com — Blood pressure medication recall. What patients need to know
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