Apotex Inc is reported to be recalling the blood pressure treatment tablets manufactured by its Bangalore based research arm. The details shared by the USFDA states the exact reason for the recall as this one lot did not meet the first stage dissolution specification limits.
This prescription only tablets were manufactured in the strength of 240 mg in 500-count bottles, and is now under the process of recall, as initiated by the Florida based Apotex Inc.
It has initiated a recall of 2,075 bottles of blood pressure treatment tablet ‘Verapamil Hydrochloride’ manufactured by Bangalore based Apotex Research due to failed dissolution specification, as confirmed by PTI.
The voluntary Class III ongoing recall for the extended-release tablets has been initiated as “one lot of product did not meet the first stage dissolution specification limits”, USFDA said in the Enforcement Report for the week of October 7, 2015.
As per the USFDA a 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.”
The tablets were being made for Florida based Apotex Corp that manufactures, markets and distributes more than 144 drugs in the United States.
Founded in 2004, Apotex Research Pvt Ltd (ARPL), is the Indian Research & Development wing of Apotex Inc.