New Delhi: Unichem Pharmaceuticals USA Inc is recalling 18,960 bottles of the hypertension treatment medication Clonidine Hydrochloride tablets in the American market for product mix-up, according to the US Food and Drug Administration. As per the latest Enforcement Report by the US health regulator, the company, a unit of Mumbai-based Unichem Laboratories, is recalling the bottles due to “product mix-up.
As per the US Food and Drug Administration (USFDA), 0.2 mg strength Clonidine Hydrochloride Tablets, USP were found in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets.
The affected lot of tables have been manufactured by Unichem Laboratories in its Goa based plant and distributed in the US market by New Jersey-based Unichem Pharmaceuticals USA Inc.
As per the USFDA, the company has initiated the Class III recall on September 19 across the US.
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.”
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market globally for pharmaceutical products.