Apotex Inc 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.
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.
The prescription only tablets were in the strength of 240 mg in 500-count bottles, it added.
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.
