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Class I Recall for Blood Pressure Drug

April 15, 2021

Alembic Pharmaceuticals Limited is recalling more than 12,000 bottles of telmisartan tablets after a bottle labelled to contain 20-mg tablets was found to contain 40-mg tablets, Alembic Pharmaceuticals Inc announced in a March 24, 2021, statement. The FDA has designated the recall Class I, its most serious of recall classes. 

According to the April 14, 2021, US Food and Drug Administration (FDA) Enforcement Report, the recall affects telmisartan tablets, 20 mg, 30-count bottles (NDC 62332-087-30), from lot 1905005661 (Exp. 3/22). The tablets were manufactured by Alembic Pharmaceuticals Limited, Gujarat, India, for Alembic Pharmaceuticals Inc. Bridgewater, NJ, and were distributed throughout the United States. 

A Class I recall designation warns that use of the affected product could cause serious adverse health consequences or death. The FDA issued the classification April 7, 2021. Alembic Pharmaceuticals Limited voluntarily initiated the recall on March 17, 2021. 

“Patients who could be on a doubled dose of telmisartan for a prolonged period of time could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening,” Alembic Pharmaceuticals Inc. warned. “To date, Alembic Pharmaceuticals Limited has not received any reports of adverse events related to this recall.” 

Telmisartan is a prescription drug used to treat hypertension.  

Jolynn Tumolo

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