An up-to-date timeline of U.S. Food and Drug Administration (FDA) approvals that could potentially impact workers' compensation. These include new drug and indication approvals, new dosages or formulations of existing products, and generics introduced to the market. Click through the interactive timeline below, or select the comprehensive list view.
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MedAlert Tag: Cardiovascular

Label Mix-Up Leads to Atenolol and Clopidogrel Recall

September 29, 2022

Golden State Medical Supply, Incorporated initiated a voluntary recall of Clopidogrel 75mg Tablets (lot# GS046745) and Atenolol 25mg Tablets (lot #GS046745) due to a label mix-up. Atenolol is indicated for the treatment of hypertension, to lower blood pressure, while Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems. Patients who suddenly stop taking atenolol are at increased risk for ischemic hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen.

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Quinapril and Hydrochlorothiazide Tablets Recalled Due to Impurity

October 25, 2022

Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg – fixed combination tablets indicated to lower blood pressure and treat hypertension – due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. The lot numbers impacted are QE2021005-A and QE2021010-A. The tablets are pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with “D” on the scored side and “19”on other side, supplied in 90’s HDPE bottle.

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