Sandoz Issues Voluntary Recall of Select Lots of Antihypertensive DrugBy
Sandoz has issued a voluntary Class III recall of 277,267 bottles of candesartan cilexetil tablets, 16 mg in select lots of a 30-count bottles and 90-count bottles. The recall was initiated in the United States on December 31, 2015 and reported in the US Food and Drug Administration’s Weekly Enforcement Report of February 17, 2016. Candesartan cilexetil is an antihypertensive.
A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The recall was due to failed impurities/degradation specifications using a nine-month stability timepoint.
The product was manufactured by Mylan Laboratories Limited in Hyderabad, India for Sandoz Inc. in Princeton, New Jersey.