Unichem Pharma recalls over 18000 bottles of Clonidine Hydrochloride tablets in US

Written by Ruchika Sharma Published On 2022-10-06T12:00:59+05:30 | Updated On 13 Oct 2023 4:15 PM IST

Unichem Pharma recalls over 18000 bottles of Clonidine Hydrochloride tablets in US

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.

New Delhi: Drugmaker, 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 (USFDA).

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 a "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.

Read also: Unichem Labs Chairman says pharma sector recovery may get delayed but not derailed

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."

Medical Dialogues team had earlier reported that Aurobindo Pharma and Unichem Laboratories had recalled 7,296 containers of hypertension drug Carvedilol tablets and 1,284 bottles of Topiramate tablets in the US market, the world's largest market for medicines, due to manufacturing issues.

Read also: Unichem, Aurobindo Pharma recall Topiramate, Carvedilol respectively in US

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.

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. The company was founded in 1944 by Late Mr. Amrut Mody. It manufactures and markets a large basket of pharmaceutical formulations as branded generics and generics worldwide.

unichem pharmaunichem pharma newshypertensionClonidine Hydrochloride tabletsUSFDA

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751