Class III Voluntary Recall Issued for High Blood Pressure Medication

As a result of a recent Enforcement Report of the U.S. Food and Drug Administration (FDA), Sun Pharma and Lupin  are recalling over 41.5 thousand drug bottles in the United States. Sun Pharmaceutical Industries Inc. is recalling 12,109 bottles of Carvediol tablets USP that are taken for treatment of high blood pressure, CNBC Money Control reports.

Sun Pharmaceutical Industries and Lupin are recalling bottles of three drugs used for different ailments including as high blood pressure, depression, and anxiety. The U.S. recall covers tablets in strengths of 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg in an ongoing voluntary nationwide recall.  The reports said the recall is due to “failed impurities/degradation specifications.”

The drugs were manufactured in Hungary by ALKALOIDA Chemical Company ZRT, a subsidiary of Sun Pharmaceuticals. Lupin is recalling 3,192 bottles of Escitalopram and 26,436 bottles of Lisinopril tablets. Escitalopram tablets are used for the treatment of depression and anxiety, while Lisinopril tablets are designed for treating hypertension (high blood pressure). The reports said that the recall of Escitalopram tablets USP in the strength of 20 mg is on account of “Labeling: incorrect or missing lot and/or expiration date.”

The product was manufactured for Lupin Pharmaceuticals Baltimore by Lupin at its Goa facility. Lupin’s recall of Lisinopril tablets for strengths of 30 mg and 40 mg is on account of GMP (Good Manufacturing Practice) deviations since the finished products were made using active pharmaceutical ingredients, whose intermediates did not meet specifications, reports CNBC Money Control.

All three voluntary recalls are Class III, noted the enforcement report. Class III recall is initiated in a situation “in which use of, or exposure to, a violative product is not likely to cause adverse health consequences,” according to the FDA.

This entry was posted in Pharmaceuticals, Product Recalls, Recalled Drugs and tagged , , , , , , . Bookmark the permalink.


© 2005-2017 Parker Waichman LLP ®. All Rights Reserved.